Takeda receives USFDA Complete Response Letter for Budesonide Oral Suspension
Osaka: Takeda Pharmaceutical Company Limited has announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) 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 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, U.S. Business Unit and Global Portfolio Commercialization, Takeda. "Takeda is assessing the details of the CRL and evaluating a regulatory path forward."
TAK-721 (budesonide oral suspension) is an oral viscous formulation of budesonide, formulated as an investigational treatment for eosinophilic esophagitis. It entered the Takeda pipeline through the company's acquisition of Shire.
Takeda Pharmaceutical Company Limited is a global, R&D-driven biopharmaceutical company headquartered in Japan. The company focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI).