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Pfizer said that the US Food and Drug Administration has approved its drug to treat adults with moderate-to-severe inflammatory bowel disease, ulcerative colitis.
The decision is based on the data from the late-stage study, in which the drug achieved all its primary and secondary goals.
The drug, Velsipity, was the key asset Pfizer picked up in its $6.7 billion deal for Arena Pharmaceuticals last year.
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Ulcerative colitis affects around 1.25 million people in the United States, according to the company.
The U.S. FDA approval was based on results from the ELEVATE UC Phase 3 registrational 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 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.