OCTOBER 13, 2023

FDA Approves S1P Receptor Modulator for Moderate to Severe UC

The FDA has approved etrasimod (Velsipity, Pfizer), a selective sphingosine-1-phosphate (S1P) receptor modulator, for adults with moderate to severe ulcerative colitis

Approval was based on results from the randomized, double-blind, placebo-controlled phase 3 trials, ELEVATE UC 52 and ELEVATE UC 12. The trials evaluated the safety and efficacy of 2 mg of etrasimod once daily in UC patients who previously failed or were intolerant to at least one approved UC therapy. Nearly two-thirds of