Ulcerative Colitis Drug Etrasimod (Velsipity) Gets FDA Approval


Adults with moderately to severely active ulcerative colitis (UC) have a new treatment option with the U.S. Food and Drug Administration’s (FDA) recent approval of the oral medication etrasimod (Velsipity).

This once-a-day pill, manufactured by Pfizer, joins Bristol Myers Squibb’s ozanimod (Zeposia) to become the second UC treatment in a class of medications called S1P receptor modulators.

The FDA granted approval based on studies evaluating Velsipity as an advanced therapy for UC patients who need new treatments for this chronic condition. Clinical trials demonstrated the safety and efficacy of the drug in patients who had previously failed or were intolerant to other UC treatments — meaning at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy.

In research published in The Lancet involving more than 400 UC patients, 27 percent receiving Velsipity achieved clinical remission (where the symptoms of IBD have lessened to the point that they’re mostly absent or gone) compared with 7 percent receiving a placebo after 12 weeks. At week 52, the percent in the drug group achieving remission rose to 32 percent, while the placebo remission rate remained the same at 7 percent.


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