FDA Approves Oral Velsipity for Ulcerative Colitis

FDA has approved Pfizer’s Velsipity (etrasimod) to treat adults with moderately to severely active ulcerative colitis. Ulcerative colitis is a chronic condition that affects an estimated 1.25 million people in the United States. Symptoms can include chronic diarrhea with blood and mucus, abdominal pain, and urgency.

Velsipity is once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator. It targets a specific part of immune that plays a role in the inflammation process involved in ulcerative colitis. Velsipity will be available in late November 2023 and will have a wholesale acquisition cost is $6,164 for 30-day bottle ($75,000 a year), according to a company spokesperson. Pfizer offers a savings plan for eligible commercially insured patients.

Michael Chiorean, M.D.

“Because of the unpredictable nature of UC, people living with the disease can cycle through several different treatments over time. Patients may also be apprehensive about using injectable therapies, like biologics,” Michael Chiorean, M.D., co-director of the IBD Center at Swedish Medical Center and an investigator in the ELEVATE Registrational Program.

The approval was based on results from the ELEVATE UC phase 3 registrational program that assessed Velsipity in patient who previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy. In ELEVATE UC 52, clinical remission was 27.0% for patients who received Velsipity compared with 7.0% for patients receiving placebo at week 12 and was 32.0% compared with 7.0% at week 52. In ELEVATE UC 12, clinical remission was achieved among 26.0% of patients receiving Velsipity compared with 15.0% of patients receiving placebo. The most common adverse reactions being headache, elevated liver tests, and dizziness. Results were published in March 2023 in The Lancet.

Velsipity is the second S1P receptor modulator approved by the FDA. The first was Bristol Myers Squibb’s Zeposia, which was approved in May 2021 to treat adults with moderately to severely active ulcerative colitis. The agency also approved Zeposia to treat patients with relapsing forms of multiple sclerosis (RMS) in March 2020. A 30-day supply of Zeposia has list price of $8,182.