FDA approves subcutaneous administration of Entyvio (vedolizumab) for maintenance therapy in moderately to severely active Crohn’s disease – Takeda

Takeda announced that the FDA has approved Entyvio (vedolizumab) subcutaneous (SC) administration for maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with intravenous (IV) 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 (UC) and is available in the U.S. as a single-dose prefilled pen (Entyvio Pen).

The approval is based on the VISIBLE 2 Study (SC CD Trial), a Phase III, 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. The primary endpoint was clinical remission at Week 52, which was defined as a total Crohn’s Disease Activity Index (CDAI) score of less than 150.

“Crohn’s disease is a complex and usually progressive disease for which an appropriate management plan is critical. My primary goal as a clinician is always to get patients to achieve remission. In VISIBLE 2, about half of patients treated with Entyvio SC achieved long-term clinical remission,” said Timothy Ritter, MD, senior medical director, Department of Research and Education, GI Alliance Research and assistant professor of medicine, TCU School of Medicine. “The data from VISIBLE 2 reaffirm the well-established efficacy profile of Entyvio, regardless of route of administration.”