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Takeda provides annual and quarterly financial highlights, statements, and data for investors. Data are available to download in Excel format.

Financial Statements and Highlights | Takeda Investor Relations

Investor

# Financial Highlights



Stay up to date on financial results, corporate milestones and learn how we're delivering on our commitment to patients, our people and the planet

## Sign up for our investors newsletter



Takeda today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. 

Takeda Announces U.S. FDA Approval of Supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) in Adult Patients with Newly Diagnosed Ph+ ALL

* ***Pre-Specified Interim Analysis Shows Positive Safety and Efficacy Results; Mezagitamab Safe and Well Tolerated ***

* ***Takeda Intends to Initiate a Global Phase 3 Trial of Mezagitamab in Patients with Primary Immune Thrombocytopenia in Fiscal Year 2024***

* ***Late-Stage Pipeline Continues to Gain Momentum With Five New Molecular Entities in Phase 3 Development in Fiscal Year 2024***

**OSAKA, Japan, and CAMBRIDGE, Massachusetts, March 13, 2024** – Takeda ([TSE:4502/NYSE:TAK](http://qz.sdachurchsierraleone.org/investors/overview/)) today announced positive topline results from a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia (ITP). Mezagitamab is a fully human immunoglobulin IgG1 monoclonal antibody (mAb) with high affinity for CD38 expressing cells (including plasmablasts, plasma cells, natural killer cells) resulting in their depletion. 

The TAK-079-1004 trial ([NCT04278924](http://clinicaltrials.gov/study/NCT04278924)) evaluated three different doses of subcutaneous mezagitamab vs placebo, given once weekly for eight weeks in patients with chronic (more than one year in duration) or persistent (3-12 months in duration) primary ITP. An interim analysis of the ongoing Phase 2 study demonstrated positive safety and efficacy results. Mezagitamab has been generally safe and well tolerated across all three cohorts. All mezagitamab doses tested demonstrated a higher platelet response rate than placebo. The increases in platelet count were dose-dependent with the greatest platelet response observed at the highest dose tested. Platelet response in mezagitamab treated patients occurred rapidly and was maintained post-therapy.
 
Based on these positive results, and following consultation with global health authorities, Takeda plans to initiate a global Phase 3 trial of mezagitamab in ITP in fiscal year 2024. When mezagitamab advances to Phase 3 in ITP Takeda will have five new molecular entities in Phase 3 development in fiscal year 2024 including TAK-279 for the treatment of psoriasis and psoriatic arthritis, TAK-861 for the treatment of narcolepsy type 1, soticlestat for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, and fazirsiran for the treatment of α1-antitrypsin associated liver disease.

ITP is a rare, IgG mediated autoimmune disease caused, in part, by the development of autoantibodies to platelets (and/or megakaryocytes), which are blood cells responsible for preventing or stopping bleeding. ITP is characterized by the accelerated destruction of platelets (with or without impaired production), resulting in a decreased platelet count and an increased risk of bleeding, which can be debilitating (including fatigue and impaired quality of life), and in severe cases may be life-threatening. The precedent for approval of new drugs in this indication requires that platelet counts be maintained at 50,000/uL or more for a sustained period. Approximately 20 percent of patients with ITP do not achieve a platelet count above 50,000/uL following treatment with available first- and second-line therapies creating significant patient burden and unmet need for a disease modifying treatment that is also tolerable.1,2 

“These Phase 2 results demonstrate mezagitamab’s compelling disease modifying mechanism of action, which has the potential to achieve disease remission for people with ITP. There remains considerable unmet need among ITP patients who may not respond or have inadequate response to prior treatment. In addition, some patients who do respond to available therapies struggle to manage side effects or relapse despite treatment,” said Chinwe Ukomadu, Head of the Gastrointestinal & Inflammation Therapeutic Area Unit at Takeda. “We look forward to initiating the Phase 3 trial and presenting these data at an upcoming scientific congress.”

Therapy with mezagitamab is designed to deliver rapid and sustained improvement in platelet response and generally rapidly restores platelet counts to functional levels. Mezagitamab previously received Orphan Drug Designation for the treatment of ITP from the U.S. Food and Drug Administration and the program recently received Fast Track Designation.

Results from the Phase 2 trial have no impact on the full year consolidated reported forecast for the fiscal year ending March 31, 2024 (Fiscal Year 2023).

## About Takeda 

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit [qz.sdachurchsierraleone.org](http://qz.sdachurchsierraleone.org/).

### Media Contacts:

#### Japanese Media

Yuko Yoneyama

[yuko.yoneyama@sdachurchsierraleone.org ](mailto:yuko.yoneyama@sdachurchsierraleone.org )

+81 70-2610-6609

#### U.S. and International Media

Chris Stamm

[chris.stamm@sdachurchsierraleone.org](mailto:chris.stamm@sdachurchsierraleone.org ) 

+1 617-374-7726

## Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question-and-answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

## Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: [http://qz.sdachurchsierraleone.org/investors/sec-filings/](http://qz.sdachurchsierraleone.org/investors/sec-filings/) or at [www.sec.gov](http://www.sec.gov/). Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

## Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

## References

1.	Provan D, Donald A, et al. *Blood Advances*. 2019;26;3(22):3780-3817.
2.	Rodeghiero F. International *Journal of Hematology*. 2023;117:316–33.

Based on positive Phase 2 results Takeda plans to initiate Phase 3 mezagitamab trial in ITP during fiscal year 2024

Takeda Announces Positive Topline Results from Phase 2 Study Evaluating Mezagitamab  (TAK-079), a Potential Best-in-Class Anti-CD38 Monoclonal Antibody, for  Primary Immune Thrombocytopenia

* ***Biological E. Limited (BE) to Manufacture Up to 50 Million Doses of QDENGA Per Year, Accelerating Takeda’s Ability to Deliver 100 Million Doses Per Year by 2030 At the Latest***

* ***Addresses the Specific Need to Offer Multi-Dose Vials for National Immunization Programs to Help Protect the Most Vulnerable Populations***

* ***Dengue Incidence Continues to Increase and Poses a Growing Threat to Public Health Worldwide***

**CAMBRIDGE, Massachusetts and HYDERABAD, India, February 26, 2024 –** Takeda ([TSE:4502/NYSE:TAK](http://qz.sdachurchsierraleone.org/investors/)) and Biological E. Limited (BE), a leading India-based Vaccines and Pharmaceutical Company, today announced a strategic partnership to accelerate access to QDENGA®▼ (Dengue Tetravalent Vaccine \[Live, Attenuated]) (TAK-003) multi-dose vials (MDVs). These doses will ultimately be made available for procurement by governments in endemic countries by 2030 at the latest to support National Immunization Programs. MDVs offer economic and logistical advantages for National Immunization Programs by minimizing packaging and storage expenses, while also reducing medical and environmental waste. BE will ramp up to a manufacturing capacity of up to 50 million doses a year, accelerating Takeda’s efforts to manufacture 100 million doses a year within the decade. The partnership will build upon existing manufacturing capacity for the vaccine at Takeda’s facility in Singen, Germany and Takeda’s long-term partnership with IDT Biologika GmbH.

“Takeda's long-term goal for our dengue program has been to make QDENGA broadly available to those at risk who may benefit from immunization. Within the last year, we've successfully launched in private markets, are now launching in some public programs, and working with partners to support a broader public health impact," said Gary Dubin, M.D., president of the Global Vaccine Business Unit at Takeda. "We are proud to announce a strategic manufacturing partnership with Biological E. Limited, which has deep expertise in vaccine manufacturing and longstanding support of public health programs around the world. Together, we will help combat dengue on a global scale by significantly increasing manufacturing capacity for multi-dose vials of QDENGA to drive sustainable access to the vaccine in more endemic countries."

Dengue fever is among the most common mosquito-borne viral diseases worldwide, with global incidence rates increasing 30-fold over the last 50 years due to urbanization, travel and climate change.1,2 Dengue is currently endemic in more than 100 countries and causes an estimated 390 million infections each year.3 The Americas, South-East Asia and Western Pacific regions are the most seriously affected, with Asia alone representing ~70% of the global burden of disease.3

“We are proud to collaborate with Takeda in the production of their groundbreaking Dengue Tetravalent Vaccine, QDENGA, in multi-dose vials,” affirmed Ms. Mahima Datla, managing director at Biological E. Limited. “Takeda’s commitment to patient-focused, value-based research and development aligns extremely well with our dedication to advancing healthcare. We are fortunate to have created an institute that attracts such strong global partners for complex vaccines and underscores our shared mission of shaping a healthier future for all. With Takeda’s esteemed history and global presence, we are honored to advance our vision of delivering highly innovative medicines and transformative care worldwide.”

QDENGA is currently available for children and adults in the private market in countries in Europe, Indonesia and Thailand, and in private and some public programs in Argentina and Brazil. TAK-003 is not approved for use in India.

## About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit [qz.sdachurchsierraleone.org](http://qz.sdachurchsierraleone.org/).

## About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to more than 130 countries and its therapeutic products are sold in India, the USA and Europe. BE currently has 8 WHO-prequalified vaccines and 10 USFDA approved Generic Injectables in its portfolio. Recently, BE has received Emergency Use Listing (EUL) from the WHO for CORBEVAX®, the COVID-19 vaccine.

In recent years, BE has embarked on new initiatives for organizational expansion such as developing specialty injectable products for global markets as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

For further details, please visit [www.biologicale.com](http://www.biologicale.com/) and follow us on [Facebook](http://www.facebook.com/Biological-E-Limited-1374756706187061/), [LinkedIn](http://www.linkedin.com/company/biological-e--ltd/) and [X](http://twitter.com/biological_e).

## About QDENGA® ▼ (Dengue Tetravalent Vaccine \[Live, Attenuated])

QDENGA® (TAK-003) is a dengue vaccine that is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four dengue virus serotypes and is designed to help protect against any of these serotypes.

In the European Union (EU) Member States, QDENGA is indicated for the prevention of dengue disease in individuals from four years of age and should be administered subcutaneously as a 0.5 mL dose at a two-dose (0 and 3 months) schedule pursuant to approved dosing regimen.

The indications for use of QDENGA may vary in different countries/regions. The use of QDENGA should be in accordance with local recommendations.

### Important Safety Information

Please consult the Summary of Product Characteristics (SmPC) before prescribing.

**Guidance for use:** QDENGA should be administered by subcutaneous injection preferably in the upper arm in the region of deltoid. QDENGA must not be injected intravascularly, intradermally or intramuscularly. Vaccination should be postponed in subjects suffering from an acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in a deferral of vaccination. Vaccination should be preceded by a review of the individual’s medical history (especially with regards to previous vaccination and possible hypersensitivity reactions which occurred after vaccination). Appropriate medical treatment and supervision must always be readily available in the event of a rare anaphylactic reaction following administration of the vaccine. Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting. A protective immune response with QDENGA may not be elicited in all vaccinees against all serotypes of dengue virus and may decline over time. It is currently unknown whether a lack of protection could result in an increased severity of dengue. It is recommended to continue personal protection measures against mosquito bites after vaccination. Individuals should seek medical care if they develop dengue symptoms or dengue warning signs.

**Contraindications:** Hypersensitivity to the active substances or excipients listed, or to previous QDENGA dose. Individuals with congenital or acquired immune deficiency, including immunosuppressive therapies such as chemotherapy or high doses of systemic corticosteroids (e.g., 20 mg/day or 2 mg/kg body weight/day of prednisone for 2 weeks or more) within 4 weeks prior to vaccination. Individuals with symptomatic HIV infection or asymptomatic HIV infection with impaired immune function. Pregnant and breast-feeding women.

▼ *This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See Section 4.8 of the SmPC for how to report adverse reactions.*

**Adverse Reactions:** Most frequently reported reactions in subjects 4 to 60 years of age were injection site pain (50%), headache (35%), myalgia (31%), injection site erythema (27%), malaise (24%), asthenia (20%), and fever (11%). Very common: (≥1/10 of subjects): upper respiratory tract infectiona, decreased appetitec, irritabilityc, headache, somnolencec, myalgia, injection site pain, injection site erythema, malaise, asthenia, fever. Common (≥1/100 to <1/10): nasopharyngitis, pharyngotonsillitisb, arthralgia, injection site swelling, injection site bruisinge, injection site prurituse, influenza like illness. aIncludes upper respiratory tract infection and viral upper respiratory tract infection. bIncludes pharyngotonsillitis and tonsillitis. cCollected in children below 6 years of age in clinical studies. dIncludes rash, viral rash, rash maculopapular, and rash pruritic. eReported in adults in clinical studies. **Refer to the SmPC for details on full side effect profile and interactions.**

For full prescribing information, please see the [Summary of Product Characteristics](http://assets-dam.sdachurchsierraleone.org/raw/upload/v1674600772/legacy-dotcom/siteassets/system/newsroom/2022/qdenga/ema-combined-h-5155-en.pdf) (SmPC) for QDENGA®▼.

Please consult with your local regulatory agency for any approved labeling in your country.

The drug information contained herein is intended to disclose corporate information. Nothing contained in this document should be considered a solicitation, promotion, or indication for any prescription drug, including those currently under development.

## About Dengue

Dengue is a mosquito-borne viral disease that spreads rapidly around the world and was one of the WHO’s top 10 threats to global health in 2019.3,4 Dengue is mainly spread by *Aedes aegypti* mosquitoes and, to a lesser extent, *Aedes albopictus* mosquitoes.3 It is caused by any of four dengue virus serotypes, each of which can cause dengue fever or severe dengue.5 The prevalence of individual serotypes varies across different geographies, countries, regions, seasons and over time.6 Recovery from infection by one serotype provides lifelong immunity against only that serotype, and later exposure to any of the remaining serotypes is associated with an increased risk of severe disease.3,7

### Takeda Media Contacts:

#### Japanese Media

Maiko Miura

<maiko.miura@sdachurchsierraleone.org>

#### U.S. and International Media

Charlotte McCormack

<charlotte.mccormack@sdachurchsierraleone.org>

### Biological E. Limited Media Contact:

K. Vijay Amruth Raj

<Vijay.Kammari@biologicale.com>

+91 83740 77433

## Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

## Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: <http://qz.sdachurchsierraleone.org/investors/sec-filings-and-security-reports/> or at [www.sec.gov](http://www.sec.gov). Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

## Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

## References

1. Ebi KL, Nealon J. Dengue in a changing climate. Environmental Research. 2016;151:115-123. doi:10.1016/j.envres.2016.07.026.

2. Messina, J.P., Brady, O.J., Golding, N. et al. The current and future global distribution and population at risk of dengue. Nat Microbiol 4, 1508–1515 (2019). <http://doi.org/10.1038/s41564-019-0476-8>.

3. World Health Organization. Dengue and Severe Dengue. World Health Organization. <http://www.who.int/en/news-room/fact-sheets/detail/dengue-and-severe-dengue>. Published March 17, 2023.

4. World Health Organization (WHO). Ten threats to global health in 2019. Retrieved July 2023.

5. CDC. About Dengue: What You Need to Know. Published April 13, 2023.

6. Guzman MG, et al. Dengue: a continuing global threat. Nature Reviews Microbiology. 2010;8:S7-S16.

7. Reich, et al. Interactions between serotypes of dengue highlight epidemiological impact of cross-immunity. J R Soc Interface 10: 20130414. <http://dx.doi.org/10.1098/rsif.2013.0414>.

Strategic Manufacturing Partnership Will Accelerate Access to Takeda’s Dengue Vaccine in Endemic Areas

Takeda and Biological E. Limited Collaborate to Accelerate Access to Dengue Vaccine in Endemic Areas

* 12 Weeks of Treatment with EOHILIA May Address Significant Unmet Needs of Patients 11 Years of Age and Older

* EoE Is a Chronic Disease That Can Significantly Impact Patients, with Esophageal Inflammation and Intermittent Symptoms of Choking and Difficult or Painful Swallowing

**OSAKA, Japan and CAMBRIDGE, Massachusetts, February 12, 2024 –** Takeda ([TSE:4502/NYSE:TAK](http://qz.sdachurchsierraleone.org/investors/)) today announced that the U.S. Food and Drug Administration (FDA) has approved EOHILIA (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE).1 It will be available in 2 mg/10 mL convenient, single-dose stick packs by the end of February.

EOHILIA is a corticosteroid indicated for 12 weeks of treatment in patients 11 years and older with EoE.1 Developed specifically for EoE, EOHILIA’s novel formulation of budesonide confers thixotropic properties – flowing more freely when shaken and returning to a more viscous state when swallowed.1,2

“Various formulations of corticosteroids have been used in the past to manage EoE, but in an off-label capacity and using multiple delivery options. With EOHILIA, it’s gratifying to now have an FDA-approved treatment specifically formulated for a consistent dose delivery with demonstrated ability to address esophageal inflammation and EoE dysphagia symptoms,” said Ikuo Hirano, MD, professor of medicine and director of the Kenneth C. Griffin Esophageal Center in the Division of Gastroenterology and Hepatology at Northwestern University Feinberg School of Medicine. “As the treatment needs and goals of patients with EoE can vary, I welcome the flexibility that EOHILIA offers as an oral medication.”

The FDA approval of EOHILIA 2 mg twice daily is based on efficacy and safety data from two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies (Study 1 and Study 2) in patients (ages 11 to 56 and 11 to 42, respectively) with EoE.1 In both studies, patients received at least one dose of either EOHILIA 2 mg twice daily or placebo orally twice daily. Efficacy endpoints included histologic remission (peak eosinophil count of ≤6 per high-powered field across all available esophageal levels) and the absolute change from baseline in patient-reported Dysphagia Symptom Questionnaire (DSQ) combined score after 12 weeks of treatment. The DSQ measures how often a patient with EoE has trouble swallowing and the behavioral adaptations they subsequently use, as reported directly by patients.3

Significantly more patients receiving EOHILIA achieved histologic remission vs. placebo in Study 1 (53.1% vs. 1%).1 In Study 2, 38% of EOHILIA patients achieved histologic remission vs. 2.4% of those in the placebo group. Absolute change from baseline in DSQ combined score in the EOHILIA vs. placebo groups in Study 1 was -10.2 (1.5) vs. -6.5 (1.8) and in Study 2, -14.5 (1.8) vs. -5.9 (2.1). During the last two weeks of each study, more patients receiving EOHILIA experienced no dysphagia or only experienced dysphagia that “got better or cleared up on its own” as compared to placebo, as measured by the DSQ. EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks. The most common adverse reactions (≥2% of patients receiving EOHILIA and at a rate greater than placebo) in Study 1 included: respiratory tract infection (13%), gastrointestinal mucosal candidiasis (8%), headache (5%), gastroenteritis (3%), throat irritation (3%), adrenal suppression (2%) and erosive esophagitis (2%). The safety profile of EOHILIA in Study 2 was generally similar to Study 1.1

“For most of us, eating is a simple experience. But for people living with eosinophilic esophagitis, sitting down for a meal can include painful and difficult swallowing, chest pain and a choking sensation,” said Brandon Monk, senior vice president and head, U.S. Gastroenterology Business Unit, Takeda. “With EOHILIA, patients and their physicians now have the first and only FDA-approved oral treatment option for EoE that was shown during two 12-week clinical studies to reduce esophageal inflammation and improve the ability to swallow.”

EoE is a chronic, immune-mediated, inflammatory disease localized in the esophagus.4 Although the exact cause is unknown, it is believed to be triggered by a variety of stimuli including certain foods and environmental allergens.5,6 The chronic inflammation of EoE can lead to a range of symptoms, which can vary by person and age, and include difficulty swallowing, vomiting and pain.7 Identifying EoE can be complex and delayed diagnosis is common among patients. If left untreated, the inflammation of EoE can worsen and narrow the esophagus, which can lead to food impaction (when food becomes stuck in the esophagus).8,9 In fact, EoE is the leading cause of emergency room visits for food impaction.10

Takeda is assessing the financial impacts of the approval, including a reversal of impairment loss for intangible assets, on the fiscal year ending on March 31, 2024 (FY2023), but does not anticipate the impact to be material.

## Indication and Limitations of Use

EOHILIA is indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE).

EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks.

## Important Safety Information

### Contraindications

EOHILIA is contraindicated in patients with hypersensitivity to budesonide. Serious hypersensitivity reactions, including anaphylaxis, have occurred with oral budesonide products.

### Warnings and Precautions

#### Hypercorticism and Adrenal Axis Suppression

Systemic effects such as hypercorticism and adrenal axis suppression may occur. Monitor patients for signs and symptoms and consider reducing the dosage of EOHILIA. Use is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) and monitoring for signs and/or symptoms of hypercorticism is recommended in patients with moderate hepatic impairment (Child-Pugh Class B).

Corticosteroids, including EOHILIA, can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to trauma, surgery, infection, or other stress situations, supplementation with a systemic corticosteroid is recommended.

#### Immunosuppression and Increased Risk of Infection

Corticosteroids, including EOHILIA, suppress the immune system and increase the risk of infection with any pathogen. Corticosteroid-associated infections can be mild, severe, and at times fatal. Monitor patients and consider discontinuation of EOHILIA if the patient develops an infection.

* **Tuberculosis reactivation may occur**. Closely monitor patients with latent tuberculosis or tuberculin reactivity while receiving EOHILIA.

* **Varicella Zoster and Measles** can be serious or fatal in non-immune patients taking corticosteroids. Avoid exposure. If a patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated. If varicella develops, treatment with antiviral agents may be considered. If a patient is exposed to measles, prophylaxis with immunoglobulin may be indicated.

* **Hepatitis B Virus Reactivation can occur.** Prior to starting EOHILIA for patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy.

* **Amebiasis**: It is recommended that latent or active amebiasis be ruled out before starting EOHILIA in patients who have spent time in the tropics or have unexplained diarrhea.

* **Avoid EOHILIA in patients with**: systemic fungal infections, known or suspected Strongyloides (threadworm) infection, cerebral malaria, and active ocular herpes simplex.

* **Localized Infections:** In clinical trials, some patients developed *Candida albicans* infections in the mouth, throat, and esophagus. Instruct patients: do not eat or drink for 30 minutes after taking EOHILIA; after 30 minutes rinse mouth with water and spit without swallowing. If oropharyngeal or esophageal candidiasis develops, treat with appropriate antifungal therapy and consider discontinuing EOHILIA.

#### Erosive Esophagitis

Erosive esophagitis occurred in subjects who received EOHILIA in a 12-week clinical trial. None of the subjects had erosions at baseline esophagogastroduodenoscopy (EGD), and most were receiving concomitant therapy with a proton pump inhibitor (PPI). Advise patients or caregivers to report new onset or worsening signs or symptoms of erosive esophagitis to their healthcare provider. Consider endoscopic evaluation as appropriate.

#### Effect on Growth

Use of corticosteroids may cause a reduction of growth velocity in pediatric patients. Monitor the growth of pediatric patients on EOHILIA. The maximum recommended duration of treatment with EOHILIA is 12 weeks.

#### Symptoms of Steroid Withdrawal in Patients Transferred from Other Systemic Corticosteroids

Monitor patients who are transferred from corticosteroids with high systemic effects to corticosteroids with lower systemic availability, such as EOHILIA, since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal axis suppression or benign intracranial hypertension, may develop. Adrenocortical function monitoring may be required in these patients and the dose of corticosteroid treatment with high systemic effects should be reduced cautiously. Replacement of systemic corticosteroids with EOHILIA may unmask allergies (e.g., rhinitis and eczema) previously controlled by the systemic drug.

#### Other Corticosteroid Effects

Monitor patients with hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, or cataracts, or with family history of diabetes, glaucoma, or with other conditions where corticosteroids may have unwanted effects.

#### Kaposi’s Sarcoma

Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement of Kaposi’s sarcoma. The maximum recommended duration of treatment with EOHILIA is 12 weeks.

#### Adverse Reactions

Most common adverse reactions (≥2%) are: respiratory tract infection, gastrointestinal mucosal candidiasis, headache, gastroenteritis, throat irritation, adrenal suppression, and erosive esophagitis.

#### Drug Interactions

Budesonide is a substrate for CYP3A4. Avoid concomitant use with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine, and grapefruit juice), which can increase systemic budesonide concentrations.

#### Use in specific Populations

* **Pregnancy**: Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Infants should be carefully observed for signs of hypoadrenalism and managed accordingly.

* **Lactation**: Lactation studies have not been conducted with EOHILIA. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EOHILIA and any potential adverse effects on the breastfed infant from EOHILIA, or from the underlying maternal condition.

* **Hepatic Impairment**: Not recommended in patients with severe hepatic impairment (Child-Pugh Class C). In patients with moderate hepatic impairment (Child-Pugh Class B), monitor for signs and/or symptoms of hypercorticism.

[Please click here for full Prescribing Information.](http://content.sdachurchsierraleone.org/?contenttype=PI&product=EOH&language=ENG&country=USA&documentnumber=1)

## Takeda’s Commitment to Gastroenterology

With this latest milestone, Takeda continues to demonstrate a commitment to meeting the very real needs of those living with gastrointestinal (GI) diseases. We believe that GI and liver diseases are life-disrupting conditions. Beyond a fundamental need for effective treatment options, we understand that improving patients’ lives also depends on their needs being recognized. With more than 35 years of experience in gastroenterology, Takeda has made significant strides in addressing patient needs with treatments for inflammatory bowel disease (IBD), acid-related diseases, short bowel syndrome (SBS) and motility disorders. We are making significant strides toward closing the gap on new areas of unmet need. Together with researchers, patient groups and more, we are working to advance scientific research and clinical medicine in GI.

## About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit [qz.sdachurchsierraleone.org](http://qz.sdachurchsierraleone.org).

### Media Contacts

#### Japanese Media

Jun Saito

<jun.saito@sdachurchsierraleone.org>

+81 3-3278-2325

#### U.S. and International Media

Amy McCarthy

<amy.mccarthy@sdachurchsierraleone.org>

+1 781-496-7761

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## Medical Information

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## References

1. EOHILIA (budesonide oral suspension) Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc.

2. Mewis J, Wagner NJ. *Advances in Colloid and Interface Science*. 2009; 214–227.

3. Hudgens S, Evans C, Phillips E, et al. *J Patient Rep Outcomes*. 2017;1(1):3.

4. Furuta GT, Katzka DA. *N Engl J Med*. 2015;373(17):1640-1648.

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6. O’Shea KM, Aceves SS, Dellon ES, et al. *Gastroenterology.* 2018;154(2):333-345. 

7. Muir AB, Brown-Whitehorn T, Gowin B, et al. *Clin Exp Gastroenterol*. 2019;12:391-399.

8. Shaheen NJ, Mukkada V, Eichinger CS, et al. *Dis Esophagus*. 2018;31(8):1-14. 

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Takeda announces the FDA approval of EOHILIA, the first FDA-approved oral therapy for eosinophilic esophagitis (EoE). EOHILIA offers a consistent dose delivery and effectively addresses esophageal inflammation and EoE dysphagia symptoms.