Takeda Announces FDA Acceptance of BLA for Subcutaneous Administration of ENTYVIO (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease

Takeda announced that the U.S. Food and Drug Administration (FDA) has accepted for 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 with ENTYVIO intravenous (IV). An application for the SC administration of ENTYVIO for the treatment of adults with moderately to severely active ulcerative colitis (UC) 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 health care professionals actively managing their care,” said Vijay Yajnik, M.D., Ph.D., vice president, head of U.S. Medical for Gastroenterology, Takeda. “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.”

The BLA package for SC administration of ENTYVIO for the treatment of adults with moderately to severely active CD is based on data from VISIBLE 2, a pivotal Phase 3 clinical trial that assessed the safety and efficacy of an SC formulation of ENTYVIO as maintenance therapy compared to placebo in 409 adult patients with moderately to severely active CD who achieved clinical response at Week 6 following two doses of open-label vedolizumab IV therapy at Weeks 0 and 2. Patients were randomized 2:1 to SC administration of ENTYVIO 108 mg or placebo every 2 weeks. Eligible patients had an inadequate response to or intolerance of corticosteroids, immunomodulators, and/or anti-tumor necrosis factor [TNF] therapies. The primary endpoint was clinical remission [defined as CD Activity Index score ≤150] at Week 52.