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TAK - Takeda's refiling for subcutaneous Entyvio gets FDA review
Takeda Pharmaceutical Company Limited American Depositary Shares
2023-04-27 09:44:03 ET
The U.S. Food and Drug Administration (FDA) accepted for review Takeda's resubmitted application seeking approval for subcutaneous (SC) administration of Entyvio as a maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) after induction therapy with Entyvio intravenous.
Takeda said the refiling was aimed to address FDA feedback in a December 2019 Complete Response Letter (CRL).
The Japanese drugmaker expects a decision from the FDA by the end of 2023.