FDA Approves Pfizer's Velsipity for Treatment of Ulcerative Colitis

The FDA approved Pfizer's Velsipity for adults with ulcerative colitis, an inflammatory bowel disease. The decision came after a late-stage study showed symptom reduction in patients using Velsipity compared to a placebo. Chemically known as etrasimod, this drug modulates the body's immune response. Velsipity offers patients a chance for steroid-free remission via a daily pill with a positive benefit-risk profile.

The U.S. Food and Drug Administration (FDA) has given the nod to Pfizer's Velsipity, for adults grappling with moderately to severely active ulcerative colitis (UC). This approval showcases a potential breakthrough for the estimated 1.25 million Americans affected by this chronic condition, characterized by symptoms such as chronic diarrhea streaked with blood and mucus, abdominal pain, and urgency. Globally, Velsipity is under review in multiple countries, with potential sales reaching $2.2 billion by 2030.

Pfizer's recent announcement has been backed by compelling results from the ELEVATE UC Phase 3 trials, which include ELEVATE UC 52 and UC 12. These trials assessed the drug's safety and effectiveness in inducing clinical remission in UC patients, especially those who had not responded or were intolerant to standard treatments like biologics or Janus kinase (JAK) inhibitor therapy.

The data revealed that 27% of patients on Velsipity achieved clinical remission by week 12, with this figure rising to 32% by week 52 in the ELEVATE UC 52 study. In ELEVATE UC 12, 26% of patients on the drug reached clinical remission. Moreover, the drug demonstrated a favorable safety profile, with common side effects including headaches, elevated liver tests, and dizziness.

“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 Angela Hwang, Chief Commercial Officer and President of Global Biopharmaceuticals Business, Pfizer. “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 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.”

Worth noting is that Velsipity, an oral, selective sphingosine-1-phosphate (S1P) receptor modulator, is not just restricted to the U.S. market. Applications for its use in treating UC are currently under review in several countries, including Canada, Australia, and Switzerland, with the European Medicines Agency also set to make its decision by early 2024.

Interestingly, Velsipity is poised to rival Bristol Myers Squibb's Zeposia, which received approval in 2021. However, unlike Zeposia, patients don't need a titration laboratory test before starting Velsipity, a factor seen as advantageous.

The global market for inflammatory bowel diseases stands at approximately $20 billion, presenting a significant opportunity for pharmaceutical giants.