Everest Medicines (HKEX 1952.HK, “Everest”, or the “Company”)’s partner Pfizer Inc. (NYSE: PFE) announced that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.
“We congratulate our partner Pfizer for achieving another significant milestone for patients in the European Union who struggle to achieve remission on conventional therapy. Etrasimod is a convenient once-daily oral treatment with a favorable benefit-risk profile, and the approval to treat patients as young as 16 years old further validates this,” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “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.”
“The approval of etrasimod in European Union is another important milestone. This new-generation S1P receptor modulator is an oral, once-daily treatment that can provide patients with a chance for corticosteroid-free remission, mucosal healing, and rapid symptom relief,” said Prof. Wu Kaichun with the First Affiliated Hospital of AFMU who is the principal investigator for etrasimod’s clinical trial in China. “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.”
The marketing authorization for VELSIPITY is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway. It follows VELSIPITY’s approval for adults with moderately to severely active UC by the U.S. Food and Drug Administration (FDA) in October 2023, and for adults with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional therapy or an advanced treatment in Canada in January 2024.
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 VELSIPITY 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. Additionally, ELEVATE UC 52 and ELEVATE UC 12 were the only studies of advanced therapies for UC to include patients with isolated proctitis, which affects approximately 30% of those diagnosed with UC. Both studies achieved all primary and key secondary efficacy endpoints, with a favorable benefit-risk profile consistent with previous studies of VELSIPITY. VELSIPITY also demonstrated improvement in the total inflammatory bowel disease questionnaire score, which measures health-related quality of life. The most common adverse reactions were lymphopenia (11%) and headache (7%).
