FDA Rejects Takeda's Eosinophilic Esophagitis Candidate, Asks For Additional Study

Takeda Pharmaceutical Co Ltd TAK received a Complete Response Letter (CRL) from the FDA for its marketing application for TAK-721 (budesonide oral suspension) for eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus.

• The CRL indicates the FDA has completed its review of the TAK-721 NDA and determined that it cannot be approved in its present form. 
• Related content: Benzinga's Full FDA Calendar.
• In addition, the FDA recommended an additional clinical study to help resolve FDA feedback. 
• “Takeda is assessing the details of the CRL and evaluating a regulatory path forward,” said Ramona Sequeira, President, U.S. Business Unit, and Global Portfolio Commercialization.
• TAK-721 (budesonide oral suspension) is an oral viscous formulation of budesonide. It entered the Takeda pipeline through the company’s acquisition of Shire.
• Price Action: TAK shares are closed at $13.75 on Tuesday.