FDA Approves Oral Drug for Ulcerative Colitis

The FDA approved a once-daily oral drug for treating moderate to severe ulcerative colitis (UC). This drug, VELSIPITY™, is a selective sphingosine-1-phosphate (S1P) receptor modulator and was developed by Pfizer, Inc. Modulating S1P receptors sequesters a specific type of immune cells in the lymph nodes so that they are not available for inflammation in sites such as the gastrointestinal tract.

The drug gained approval after “two independent randomised, multicentre, double-blind, placebo-controlled, phase 3 trials” showed more patients achieved remission after taking VELSIPITY compared to the placebo group. The results of the clinical trial was published in The Lancet article title “Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies.”

More information on VELSIPITY can be found here.

Citation:

U.S. FDA approves Pfizer’s VELSIPITYTM for adults with moderately to severely active ulcerative colitis (UC). Business Wire. (2023, October 13). https://www.businesswire.com/news/home/20231012073213/en/U.S.-FDA-Approves-Pfizer%E2%80%99s-VELSIPITY%E2%84%A2-for-Adults-with-Moderately-to-Severely-Active-Ulcerative-Colitis-UC