FDA spooks Takeda's first EoE approval hopes, issuing CRL on TAK-721

Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502) yesterday announced that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration in response to its New Drug Application (NDA) for TAK-721 (budesonide oral suspension) for the treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus.

The CRL indicates the FDA has completed its review of the TAK-721 (intended trade name Eohilia) NDA and determined that it cannot be approved in its present form. In addition, the FDA recommended an additional clinical study in order to help resolve FDA feedback.

“We are disappointed by the outcome of the FDA’s review of TAK-721, and that EoE patients will still be without a treatment option that the FDA has approved as safe and effective,” said Ramona Sequeira, president, US Business Unit and Global Portfolio Commercialization, Takeda, adding: “Takeda is assessing the details of the CRL and evaluating a regulatory path forward.”