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# FDA OKs Pfizer Ulcerative Colitis Drug
- URL: https://www.fdaweb.com/fda-oks-pfizer-ulcerative-colitis-drug/
- Published: 2023-10-13T12:00:00.000Z
- Updated: 2026-09-14T19:02:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155558

FDA has approved a Pfizer NDA for Velsipity (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate receptor modulator for adults with moderately to severely active ulcerative colitis (UC). “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,” the company says.

Approval was based on data from the ELEVATE UC Phase 3 program (ELEVATE UC 52 and ELEVATE UC 12) that evaluated the safety and efficacy of Velsipity 2 mg once-daily on clinical remission in UC patients who did not improve on a previous conventional, biologic, or Janus kinase inhibitor therapy, Pfizer says. “Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of Velsipity,” it says.

Specifically, the data showed that clinical remission was 27.0% for patients receiving Velsipity compared to 7.0% for patients receiving placebo at Week 12, and 32.0% compared to 7.0% at Week 52, Pfizer says. “In ELEVATE UC 12, clinical remission was achieved among 26.0% of patients receiving Velsipity compared to 15.0% of patients receiving placebo…,” it adds.