Takeda Pharmaceutical Co. Ltd. (TAK) announced Wednesday 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).
The company said 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.
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, a pivotal Phase 3 clinical trial.
The trial 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.
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