FDA Approves Velsipity for Moderate-to-Severe Ulcerative Colitis in Adults

FDA Approves Velsipity for Moderate-to-Severe Ulcerative Colitis in Adults

The U.S. Food and Drug Administration approved Velsipity (etrasimod) for adults with moderately to severely active ulcerative colitis (UC).

The selective sphingosine-1-phosphate receptor modulator was approved at a 2-mg recommended dose. The safety of Velsipity was consistent with previous studies, with the most common adverse reactions being headache, elevated liver tests, and dizziness (incidence ≥5 percent).

“Velsipity provides adults living with moderately-to-severely active UC the opportunity to achieve steroid-free remission with an oral, once-daily pill that has a favorable benefit-risk profile,” Angela Hwang, Pfizer chief commercial officer and president of global biopharmaceuticals business, said in a statement.

Approval of Velsipity was granted to Pfizer.