Everest Medicines, in collaboration with Pfizer Inc., has announced a significant breakthrough in ulcerative colitis (UC) treatment as the European Commission (EC) grants marketing authorization for VELSIPITY® (etrasimod) in the European Union. 

This approval allows for the treatment of patients 16 years of age and older with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to conventional therapy or a biological agent.

VELSIPITY, hailed as a convenient once-daily oral treatment with a favorable benefit-risk profile, represents a pivotal advancement in addressing the unmet needs of UC patients. Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines, expressed congratulations to Pfizer for achieving this milestone, emphasizing the significance for patients across the European Union.

Luo further stated Everest's commitment and said, "Everest will advance our Phase 3 study in Asia as quickly as possible and plans to submit a New Drug Application in Greater China this year, as the incidence of UC has been rapidly increasing in this region."

Prof. Wu Kaichun, from the First Affiliated Hospital of AFMU and principal investigator for etrasimod's clinical trial in China, lauded the approval of etrasimod in the European Union as an essential milestone. "Patient recruitment for the Phase 3 clinical trial in Asia was completed and positive 12-week data have been reported. We hope China and other Asian countries can obtain approval as soon as possible to benefit more patients," he said.

The marketing authorization for VELSIPITY encompasses all 27 EU member states as well as Iceland, Liechtenstein, and Norway. This follows previous approvals by the U.S. Food and Drug Administration (FDA) in October 2023 and Health Canada in January 2024.

The approval by the European Commission was based on robust data from the ELEVATE UC Phase 3 registrational program, including studies ELEVATE UC 52 and ELEVATE UC 12. These trials evaluated the safety and efficacy of VELSIPITY in UC patients who had previously failed or were intolerant to conventional, biologic, or Janus kinase (JAK) inhibitor therapy. Notably, these studies included patients with isolated proctitis, a subgroup often overlooked in clinical trials.

VELSIPITY demonstrated positive outcomes across primary and key secondary efficacy endpoints, with a favorable benefit-risk profile consistent with previous studies. Adverse reactions were generally mild, with lymphopenia and headache being the most common.