Pfizer's (PFE) Ulcerative Colitis Pill Etrasimod Gets FDA Nod

Pfizer PFE announced that the FDA has granted approval to its oral, once-daily pill called etrasimod to treat moderately-to-severely active ulcerative colitis (UC). The oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator will be marketed by the brand name of Velsipity (2 mg dose).

The approval for etrasimod was based on data from two pivotal phase III studies, ELEVATE UC 52 and ELEVATE 12. These studies evaluated the safety and efficacy of a daily 2mg dose of oral etrasimod in UC patients who had failed treatment with a JAK inhibitor. Both studies achieved their primary endpoint of clinical remission over placebo and all key secondary endpoints.

An application seeking the approval of etrasimod is also under review in the EU, with a decision from the European Medicines Agency anticipated in first-half 2024.

Velsipity (etrasimod) was added to Pfizer’s inflammation and immunology portfolio with the March 2022 acquisition of Arena Pharmaceuticals.

The oral, once-daily pill for UC, a chronic condition, is an advanced therapy, which, if approved, will offer patients an opportunity to achieve steroid-free remission.

Pfizer’s stock has declined 37.4% so far this year against an increase of 8.5% for the industry.