FDA Accepts Review of Takeda’s Biologics License Application for Entyvio

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Submission to focus on maintenance therapy in adults with moderately to severely active Crohn’s disease.

Takeda broke the news that the FDA has agreed to review its biologics license application (BLA) for the investigational subcutaneous (SC) administration of Entyvio (vedolizumab) for maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy. According to the company, another application for the SC administration of the treatment for adults with moderately to severe active ulcerative colitis is also under review by the FDA.


“With two applications for a subcutaneous option of Entyvio now under FDA review, we remain firm in our commitment to the inflammatory bowel disease community—adults with ulcerative colitis or Crohn’s disease—and the healthcare professionals actively managing their care,” said Vijay Yajnik, MD, PhD, VP, head of US medical for gastroenterology, Takeda, in a company press release. “Every patient journey is different, and every patient has a unique set of medical needs and personal preferences. We strongly believe in meeting those needs—providing both an IV and a subcutaneous administration option for Entyvio, pending approval, is one way we can do that.”

Reference: Takeda Announces FDA Acceptance of BLA for Subcutaneous Administration of ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease. Takeda. September 13, 2023. Accessed September 13, 2023. https://www.takeda.com/newsroom/newsreleases/2023/Takeda-Announces-FDA-Acceptance-of-BLA-for-Subcutaneous-Administration-of-ENTYVIO-vedolizumab-for-Maintenance-Therapy-in-Moderately-to-Severely-Active-Crohn-Disease/