FDA Accepts for Review Takeda’s TAK-721 NDA Resubmission

OSAKA, Japan and CAMBRIDGE, Massachusetts, September 20, 2023 – Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) resubmission for TAK-721 (budesonide oral suspension) which is being investigated for the short-term treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease that can cause damage to the esophagus.¹ The resubmission is intended to address previous FDA feedback to the Company’s original NDA submission.

“Takeda’s focus on TAK-721 is driven by our belief that there are significant unmet treatment needs in the EoE community,” said Vijay Yajnik, M.D., Ph.D., vice president, head of U.S. Medical for Gastroenterology, Takeda. “Over the past several months, we’ve reanalyzed the TAK-721 clinical data and pursued a dialogue with the FDA because we recognize EoE patients need additional therapeutic options. As a result of that constructive discussion, we have resubmitted our NDA with a revised proposed indication, for short-term treatment of EoE.”

Takeda expects a decision from the FDA during the first half of 2024.

Takeda’s Commitment to Gastroenterology

With this latest milestone, Takeda continues to demonstrate a commitment to meeting the very real unmet needs of those living with gastrointestinal diseases. For more than 30 years, gastroenterology has been a core focus area for Takeda. We understand that GI conditions can be debilitating, painful and disrupting, and are dedicated to our goal of delivering life-transforming treatments that make a meaningful difference in patient lives.

About TAK-721 (budesonide oral suspension)

TAK-721 (budesonide oral suspension) is a novel mucoadherent topically active oral viscous formulation of budesonide, formulated specifically as an investigational treatment for eosinophilic esophagitis (EoE).² The suspension is intended to treat the localized esophageal inflammation that is caused by EoE.

About Eosinophilic Esophagitis (EoE)

Eosinophilic esophagitis (EoE) is a chronic, immune-mediated, inflammatory disease localized in the esophagus.¹ Although the exact cause of EoE is unknown, it is believed to be triggered by a variety of stimuli including certain foods and environmental allergens.³ 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 heartburn.⁴ If left untreated, inflammation of EoE can worsen and narrow the esophagus, which can lead to food impaction.⁵

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 www.takeda.com.

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U.S. and International Media

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References

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

2. Dellon ES, et al. Clin Gastroenterol Hepatol. 2019;17:666–673.

3. Clayton F, Peterson K. Gastrointest Endosc Clin N Am. 2018;28(1):1-14.

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

5. Hirano I, Furuta GT. Gastroenterology. 2020;158(4):840-851.