U.S. Food and Drug Administration Accepts New Drug Application for Review, Grants Priority Review for Takeda’s TAK-721 (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis
− If approved, TAK-721 will be the first FDA-approved treatment for the chronic inflammatory disease; Takeda plans to use the trade name Eohilia (budesonide oral suspension)
“For too long, healthcare professionals have been without approved treatments developed specifically to target the chronic, localized esophageal inflammation of EoE,” said
EoE is a chronic inflammatory disease that can cause damage to the esophagus.2 Impacting approximately one in 2,000 people in the
“Because food is so integral to our social lives and well-being, many facets of everyday life are impacted by the symptoms of EoE,” said
The TAK-721 development program is the first and largest EoE Phase 3 clinical trial program in the
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).1 The suspension is intended to treat the localized esophageal inflammation that is caused by EoE.
Priority Review, Breakthrough Therapy designation and Orphan Drug designation do not guarantee approval or commercial availability.
About Eosinophilic Esophagitis (EoE)
Eosinophilic esophagitis (EoE) is a chronic, immune-mediated, inflammatory disease localized in the esophagus.2 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.8 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.9 If left untreated, inflammation of EoE can worsen and narrow the esophagus, which can lead to food impaction11 that may necessitate urgent endoscopic intervention.13 Currently, there are no FDA-approved therapeutic options for the treatment of EoE, though current management guidelines for EoE recommend the elimination of targeted food from patient diets, the use of proton pump inhibitors and/or treatment with topical glucocorticosteroids.14
Takeda’s Commitment to Gastroenterology in
Takeda sees an urgent need for improving patient care in gastroenterology (GI) and has focused on improving the lives of patients through the delivery of innovative medicines and dedicated patient disease support programs for more than 25 years. We push boundaries and work across modalities, taking on the most complex GI conditions and the most neglected patient needs, boldly advancing original thinking and creatively tackling barriers to make a meaningful difference for patients. Challenging expectations and enabling innovative thinking, Takeda is part of more than 200 collaborations connecting people with a mutual commitment to action. Takeda is leading in areas of gastroenterology associated with high unmet need, such as inflammatory bowel disease, short bowel syndrome, and motility and esophageal disorders. Our
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References
1 Dellon ES, et al. Clin Gastroenterol Hepatol. 2019;17:666–673.
2 Furuta GT, Katzka DA. N Engl J Med. 2015;373(17):1640-1648.
3 O'Shea KM, Aceves SS, Dellon ES, et al. Gastroenterology. 2018;154(2):333-345.
4 Dellon ES. Gastroenterol Clin North Am. 2013;42(1):133-153.
5 Dellon ES, Jensen ET, Martin CF, et al. Clin Gastroenterol Hepatol. 2014;12(4):589-596.
6 Dellon ES. Gastroenterol Clin North Am. 2014;43(2):201-218.
7 Dellon ES, Hirano I. Gastroenterology. 2018;154(2):319-332.e3.
8 Clayton F, Peterson K. Gastrointest Endosc Clin N Am. 2018;28(1):1-14.
9
10 Carr S, Chan ES, Watson W. Allergy Asthma Clin Immunol. 2018;14(Suppl 2):58.
11 Hirano I, Futura GT. Gastroenterology. 2020;158(4):840-851.
12 U.S.
https://clinicaltrials.gov/ct2/results?recrs=e&type=Intr&cond=Eosinophilic+Esophagitis&phase=2&fund=2.
Accessed
13 Schupack D. et al.
14 Hirano I, Bernstein KA, Jonathan A. et al. Gastroenterology. 2020;158(6):1776-1786.
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