Takeda, a global biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) resubmission for TAK-721 (budesonide oral suspension). This drug is under investigation for the short-term treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease that can damage the esophagus. The resubmission aims to address the FDA’s feedback on Takeda’s original NDA submission.
Key points from the article:
Background: Takeda’s resubmission for TAK-721 is driven by the significant unmet treatment needs in the EoE community. The company has reanalyzed the clinical data of TAK-721 and engaged in discussions with the FDA. As a result, they have resubmitted their NDA with a revised proposed indication for the short-term treatment of EoE.
FDA Decision Timeline: Takeda anticipates a decision from the FDA during the first half of 2024.
About TAK-721: TAK-721 is a novel mucoadherent topically active oral viscous formulation of budesonide, specifically formulated as an investigational treatment for EoE. The suspension aims to treat the localized esophageal inflammation caused by EoE.
Eosinophilic Esophagitis (EoE) Overview: EoE is a chronic, immune-mediated inflammatory disease localized in the esophagus. It’s believed to be triggered by various stimuli, including certain foods and environmental allergens. Chronic inflammation from EoE can lead to symptoms like difficulty swallowing, vomiting, and heartburn. If untreated, it can worsen and narrow the esophagus, potentially leading to food impaction.
Takeda’s Commitment: Takeda has been dedicated to the field of gastroenterology for over 30 years, aiming to address the unmet needs of those living with gastrointestinal diseases.