Takeda: FDA Accepts NDA Resubmission Of TAK-721 For Short-Term Treatment Of Eosinophilic Esophagitis

(RTTNews) - Takeda Pharmaceutical Co. Ltd. (TAK) announced Wednesday that the U.S. Food and Drug Administration has accepted for review its New Drug Application or NDA resubmission for TAK-721 (budesonide oral suspension) for the short-term treatment of Eosinophilic Esophagitis or EoE.

The resubmission is intended to address previous FDA feedback to the company's original NDA submission. The company expects a decision from the FDA during the first half of 2024.

EoE is a chronic inflammatory disease that can cause damage to the esophagus. It is believed to be triggered by a variety of stimuli including certain foods and environmental allergens.

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

Vijay Yajnik, 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."

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