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Pfizer Says FDA Approves VELSIPITY For Adults With Moderately To Severely Active Ulcerative Colitis
(RTTNews) - Pfizer Inc. (PFE) announced Friday that the U.S. Food and Drug Administration (FDA) has approved VELSIPITY (etrasimod) for adults with moderately to severely active ulcerative colitis (UC).
VELSIPITY is an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5. The approved recommended dose for VELSIPITY is 2 mg.
The U.S. FDA approval was based on results from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12 pivotal trials). The program evaluated the safety and efficacy of VELSIPITY 2 mg once-daily on clinical remission in UC patients who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy.
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 to include patients with isolated proctitis.
Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of VELSIPITY.
UC is a chronic and often debilitating condition1 that affects an estimated 1.25 million people in the U.S.
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