FDA acceptance of NDA resubmission of TAK 721 (budesonide oral suspension) for the short-term treatment of eosinophilic esophagitis
Takeda announced that the 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
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.
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