FDA approves subcutaneous administration of Takeda’s ENTYVI in Crohn’s disease

Takeda “announced that the FDA has approved ENTYVIO subcutaneous administration for maintenance therapy in adults with moderately to severely active Crohn’s disease after induction therapy with intravenous ENTYVIO. The subcutaneous administration of ENTYVIO was also approved by FDA in September 2023 for the maintenance treatment of adults with moderately to severely active ulcerative colitis and is available in the U.S. as a single-dose prefilled pen. The approval is based on the VISIBLE 2 Study (SC CD Trial), a Phase 3, randomized, double-blind, placebo-controlled trial, which assessed the safety and efficacy of an SC formulation of ENTYVIO as maintenance therapy in adult patients with moderately to severely active CD who had clinical response** at Week 6 following two doses of open-label vedolizumab intravenous therapy at Weeks 0 and 2.1 The primary endpoint was clinical remission at Week 52, which was defined as a total Crohn’s Disease Activity Index score of less than or equal to150.”