FDA Approves New Oral Treatment for Ulcerative Colitis

The US Food and Drug Administration (FDA) approved etrasimod 2mg to treat adults with moderate to severe ulcerative colitis (UC), Pfizer announced on October 13, 2023.

The approval was based on the results from 2 randomized, double-blind, placebo-controlled phase 3 trials, ELEVATE UC 52 and ELEVATE UC 12. The trials evaluated the safety and efficacy of etrasimod 2mg for patients currently in clkinical remission who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy.

In ELEVATE UC 12, 26% of patients treated with etrasimod achieved clinical remission compared to the patients treated with placebo (15%).

In ELEVATE UC 52, 32% of patients treated with etrasimod achieved clinical remission vs 7% of the placebo group after 52 weeks of therapy.

Etrasimod is an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for adults. Common adverse effects include headache, elevated liver tests and dizziness

Etrasimod is expected to be available starting late November 2023.

Reference:
U.S. FDA approves Pfizer’s VELSIPITY™ for adults with moderately to severely active ulcerative colitis (UC). Press release. US Food and Drug Administration. October 13, 2023. Accessed October 13, 2023.