FDA OKs Pfizer's New Bowel Disease Drug, Analysts Predict Peak Sales Of $3B A Year

The Food and Drug Administration (FDA) approved Pfizer Inc's PFE Velsipity (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC). 

The approved recommended dose for VELSIPITY is 2 milligrams.

Symptoms of UC, which affects some 1.25 million people in the U.S., include chronic diarrhea with blood, mucus and abdominal pain.

Velsipity will compete with Bristol Myers Squibb Co's BMY Zeposia, which was approved in 2021.

The global market for inflammatory bowel disease treatment is about $20 billion.

Reuters, citing analysts, expects peak sales for the Pfizer drug to top $3 billion a year.

The FDA approval was based on results from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12).

Nearly two-thirds of patients in ELEVATE UC 52 and ELEVATE UC 12 were naïve to biologic or JAK inhibitor therapy, and these studies were also the only studies for advanced therapies for ulcerative colitis, including patients with isolated proctitis. 

In ELEVATE UC 52, clinical remission was 27% for patients receiving VELSIPITY compared to 7% for patients receiving placebo at week 12 and was 32% compared to 7% at week 52. 

In ELEVATE UC 12, clinical remission was achieved among 26% of patients receiving VELSIPITY compared to 15% of patients receiving placebo. 

Price Action: PFE shares are down 1.94% at $32.28 on the last check Friday.

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