Pfizer has received the green light from the U.S. Food and Drug Administration (FDA) for VELSIPITY, also known as etrasimod, an oral medication that is taken once daily and selectively modulates the sphingosine-1-phosphate (S1P) receptor.
This approval is specifically for adults who are dealing with moderately to severely active ulcerative colitis (UC), a chronic and often disabling condition affecting an estimated 1.25 million individuals in the United States.
The recommended dose for 2 mg Symptoms of UC can be distressing and encompass chronic diarrhea with blood and mucus, abdominal pain, and a compelling sense of urgency, and the impact goes beyond the physical aspect due to the chronic and unpredictable nature of the symptoms.
The FDA approval was grounded on the promising outcomes of the ELEVATE UC Phase 3 registrational program, specifically the ELEVATE UC 52 and ELEVATE UC 12 trials. These trials evaluated the safety and efficacy of VELSIPITY 2 mg once daily in inducing clinical remission among UC patients who had previously failed or were intolerant to at least one conventional treatment, biologic, or Janus kinase (JAK) inhibitor therapy. Notably, a significant proportion of patients in these trials were treatment-naïve to biologic or JAK inhibitor therapy.
The studies achieved all primary and key secondary efficacy endpoints, while maintaining a safety profile consistent with previous VELSIPITY studies.
In the ELEVATE UC 52 trial, patients treated with VELSIPITY demonstrated a substantial increase in clinical remission rates compared to those on placebo at both week 12 and week 52. at both week 12 and week 52 Similarly, in the ELEVATE UC 12 trial, a noteworthy proportion of patients on VELSIPITY achieved clinical remission compared to the placebo group at week 12. These findings, along with positive outcomes in key secondary endpoints like endoscopic improvement and mucosal healing, substantiated the efficacy of VELSIPITY in treating UC. VELSIPITY represents a significant advancement as a once-daily, oral medication that selectively binds with specific S1P receptor subtypes.
Regulatory applications for VELSIPITY's approval in treating ulcerative colitis have been submitted in various countries worldwide, including Canada, Australia, Mexico, Russia, Switzerland, and Singapore. The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for VELSIPITY, and a decision from EMA is expected in the early months of 2024.
The pivotal ELEVATE UC 52 trial was designed with a 12-week induction period followed by a 40-week maintenance period, employing a randomized, double-blind, placebo-controlled approach. The primary goal was to assess the safety and efficacy of etrasimod 2 mg once daily on clinical remission after both 12 and 52 weeks. The trial demonstrated significant improvements in primary and key secondary endpoints, including endoscopic improvement and mucosal healing.
Similarly, the ELEVATE UC 12 trial, which was also randomized and placebo-controlled, focused on assessing the efficacy and safety of etrasimod 2 mg once daily in subjects with moderately to severely active UC. The trial achieved its primary objective, showcasing a noteworthy proportion of patients achieving clinical remission with etrasimod compared to the placebo group at week 12 at week 12
Importantly, the safety profile of VELSIPITY was consistent across both trials, with common adverse reactions being manageable and not unexpected. These trials affirm that initiating VELSIPITY treatment does not necessitate a complex up-titration regimen, enhancing its practicality and ease of use for patients
