Takeda Announces FDA Acceptance of NDA Resubmission of TAK-721 (budesonide oral suspension) for the Short-Term Treatment of Eosinophilic Esophagitis (EoE)
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“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
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
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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.
US-BOS-0521v1.0 09/23
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Jun Saito
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Amy McCarthy
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Source: Takeda Pharmaceutical Company Limited