FDA approves Pfizer’s ulcerative colitis drug

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FDA approves Pfizer’s ulcerative colitis drug

Today Pfizer announced the FDA’s approval of VELSIPITY, an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC), a condition that produces debilitating symptoms such as chronic diarrhea with blood and mucus, abdominal pain, and urgency and affects approximately 1.25 million people in the United States. 

“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,” said Chief Commercial Officer and President of Global Biopharmaceuticals Business, Pfizer Angela Hwang in a press release. “VELSIPITY’s FDA approval today marks a significant milestone for UC patients who need new treatments for this chronic condition and are ready to start advanced therapy.”

“Because of the unpredictable nature of UC, people living with the disease can cycle through several different treatments over time. Patients may also be apprehensive about using injectable therapies, like biologics,” said Dr. Michael Chiorean, Co-Director of the IBD Center at Swedish Medical Center and an investigator in the ELEVATE Registrational Program. “It’s important to have new, effective options like VELSIPITY for those patients who may require an advanced treatment option and prefer the convenience of a once-daily pill. VELSIPITY is a proven advanced treatment with a favorable benefit-risk profile.”

FDA approved a 2-mg recommended dose for VELSIPITY. The regulatory green light 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.

Read more about FDA’s approval for Pfizer’s VELSIPITY™ for Adults with Moderately to Severely Active Ulcerative Colitis (UC)