Everest Medicines announced that the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China has approved the New Drug Application (NDA) for VELSIPITY® (etrasimod) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). It marks the first approval of VELSIPITY® in Everest territories. VELSIPITY® is an effective and convenient, once-daily, oral treatment for patients with moderately to severely active UC that has already been approved in the U.S. and E.U., by Everest's licensing partner, Pfizer.

VelsIPITY® is the first and only advanced oral UC therapy approved for use in patients 16 years of age or older in the EU. The 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 etrasimod 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 etrasimod. Everest is conducting a multicenter, randomized, double-blind and placebo-controlled Phase 3 trial of etrasimod in Asian countries, including mainland China, China Taiwan and South Korea. Patients with inadequate response or intolerance to at least one conventional, biologic, or JAK inhibitor therapy were randomized to receive etrasimod 2mg once-daily or placebo for 12 weeks of induction treatment.

Etrasimod treatment resulted in a clinically meaningful and statistically significant improvement in the primary endpoint and all key secondary and other secondary endpoints (including mucosal healing, symptomatic remission and endoscopic normalization) after the 12-week induction treatment period. In general, treatment with etrasimod 2mg was well tolerated. The safety profile was consistent with previous etrasimod studies and no new safety findings were observed.

Patients who responded to induction treatment were then re-randomized to receive 2mg once-daily etrasimod or placebo maintenance treatment for 40 weeks. The data for maintenance period is expected for readout in second half 2024.