FDA Approves Subcutaneous Vedolizumab for Maintenance Therapy in Crohn’s Disease

The U.S. Food and Drug Administration (FDA) on April 18 announced its approval of subcutaneous (SC) administration of vedolizumab for maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with intravenous vedolizumab.

The agency approved SC vedolizumab in September 2023 for the maintenance treatment of adults with moderately to severely active ulcerative colitis (UC).

The formulation is available in the US as a single-dose prefilled pen.

The approval is based on the VISIBLE 2 study, a phase 3, randomized, double-blind, placebo-controlled trial, which assessed the safety and efficacy of an SC formulation of vedolizumab 108 mg as maintenance therapy in adult patients with moderately to severely active CD who achieved 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 ≤150.

The vedolizumab SC safety profile was generally consistent with the known safety profile of vedolizumab IV, with the addition of injection site reactions such as erythema, rash, pruritus, swelling, bruising, hematoma, pain, urticaria, and edema.

Reference:

U.S. FDA approves subcutaneous administration of Takeda’s ENTYVIO® (vedolizumab) for maintenance therapy in moderately to severely active Crohn’s disease. News release. Takeda; April 19, 2024. Accessed April 22, 2024. https://www.takeda.com/newsroom/newsreleases/2024/fda-approves-subcutaneous-administration-of-entyvio/