FDA Approves Subcutaneous Vedolizumab for Maintenance of UC

The U.S. Food and Drug Administration (FDA) on September 27 approved subcutaneous (SC) vedolizumab for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) after induction therapy intravenous vedolizumab. The single-dose prefilled pen should be available by the end of October, according to the manufacturer, Takeda Pharmaceuticals.

The approval of this new route of administration for vedolizumab is based on VISIBLE 1, a phase 3, randomized, double-blind, placebo-controlled trial that assessed the safety and efficacy of the SC formulation of vedolizumab as maintenance therapy among adult patients with moderately to severely active UC who achieved clinical response at Week 6 following 2 doses of open-label vedolizumab intravenous therapy at Weeks 0 and 2.

Among patients receiving vedolizumab SC 108 mg maintenance therapy administered every 2 weeks , 45% achieved clinical remission— defined as a complete Mayo score of ≤2 points and no individual subscore >1 point at Week 52—compared to 14% of patients receiving placebo.