The FDA has given its approval for the subcutaneous administration of Takeda Pharmaceuticals’ Entyvio as a maintenance therapy for adult patients with moderate-to-severe ulcerative colitis. This approval follows the induction therapy via IV administration of the biologic. The IV formulation of Entyvio was initially approved in 2014 for both moderate-to-severe ulcerative colitis and Crohn’s disease. The new formulation of Entyvio is anticipated to be available as a single-dose pre-filled pen within the upcoming month.
Key Points:
Purpose and Efficacy: The Galleri® test can detect signals from over 50 types of cancer, many of which currently lack recommended screening tests. When a cancer signal is detected, the test can predict its origin with high accuracy.
Benefits to Patients: Brandon Monk, Senior Vice President at Takeda, highlighted that with the FDA’s approval, patients and physicians now have two choices for maintenance treatment for adults with moderate to severe ulcerative colitis. The options are either intravenous or subcutaneous administration.
Clinical Trial Results: The FDA’s decision was based on the VISIBILE 1 trial. This phase 3 trial assessed the safety and efficacy of subcutaneous vedolizumab as maintenance therapy. At week 52, a significant proportion of patients who received subcutaneous vedolizumab achieved clinical remission compared to those on placebo (46% vs. 14%).
Safety Profile: The safety profile of subcutaneous vedolizumab was found to be consistent with its IV counterpart. However, there were some injection site reactions reported with the subcutaneous administration.
Expert Opinion: Dr. Bruce Sands from the Icahn School of Medicine at Mount Sinai stated that the VISIBLE 1 trial showcased that Entyvio SC offers an additional administration option for achieving remission in moderate to severe ulcerative colitis patients.