China-based pharmaceutical company Everest Medicines (HKG: 1952) announced that its licensing partner, Pfizer Inc. (NYSE: PFE), has secured market approval from the US FDA for Velsipity (etrasimod). This oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator is indicated for adults with moderately to severely active ulcerative colitis (UC), marking a significant advancement in the treatment of this chronic condition.
Clinical Trial Success and FDA Approval
The FDA approval is based on positive results from the ELEVATE UC Phase III regulatory trials (ELEVATE UC 52 and ELEVATE UC 12), which 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. These trials were notable for including nearly two-thirds of patients who were naïve to biologic or JAK inhibitor therapy and for being the only studies for advanced UC therapies 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.
Global Regulatory Submissions and Licensing Deal
Regulatory applications for etrasimod in ulcerative colitis have been submitted to countries around the world for review, including Canada, Australia, Mexico, Russia, Switzerland, and Singapore. The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for etrasimod, with a decision anticipated in early 2024. Everest Medicines secured a licensing deal with Pfizer’s subsidiary Arena Pharmaceuticals in 2017, obtaining development rights to the drug in Greater China and South Korea, highlighting the drug’s potential in key Asian markets.-Fineline Info & Tech
