Everest Medicines' Partner Pfizer Announces European Commission Approves VELSIPITY® for Patients with Moderately to Severely Active Ulcerative Colitis
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The European Commission's approval of VELSIPITY for ulcerative colitis represents a significant regulatory milestone for Everest Medicines and its partner Pfizer. The authorization expands the treatment landscape for UC patients in the EU, offering a novel oral therapy option. The regulatory decision is based on the comprehensive ELEVATE UC Phase 3 program, which demonstrated the drug's efficacy and safety in a patient population that included those with isolated proctitis—a subset not always covered in clinical trials for UC. This inclusion could indicate a broader therapeutic scope for VELSIPITY and potentially influence future clinical trial designs to be more inclusive of this patient group.
VELSIPITY's mechanism of action as an S1P receptor modulator distinguishes it from conventional UC therapies and positions it as a potential first-line treatment for patients who are unresponsive or intolerant to other medications. The drug's ability to provide corticosteroid-free remission and mucosal healing addresses critical unmet needs in UC management. The reported improvement in health-related quality of life, as measured by the total inflammatory bowel disease questionnaire score, underscores the potential impact of VELSIPITY on patient well-being beyond mere symptom control. However, the reported adverse reactions, including lymphopenia in 11% of patients, warrant continued post-marketing surveillance to ensure long-term safety.
The approval of VELSIPITY in the EU, following its FDA and Health Canada authorizations, signifies a growing global footprint for the therapy. This expansion into the EU market could have positive financial implications for Everest Medicines and Pfizer, particularly as the incidence of UC is reportedly on the rise in Asia, indicating a large potential market. Everest Medicines' plans to submit a New Drug Application in Greater China within the year could further extend the drug's market presence. The company's strategy to expedite the Phase 3 study in Asia and leverage positive 12-week data could accelerate market penetration and uptake in this region, provided regulatory approval is obtained. Stakeholders should monitor Everest's progress in Asia, as it could significantly influence the company's valuation and market share in the UC treatment space.
--VELSIPITY is the first and only oral advanced ulcerative colitis therapy approved for use in patients 16 years of age or older in the EU--
"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
"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
The marketing authorization for VELSIPITY is valid in all 27 EU member states as well as
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
About VELSIPITY® (etrasimod)
VELSIPITY is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5. Regulatory applications for VELSIPITY in ulcerative colitis have been submitted to additional countries including
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include cardio-renal diseases, autoimmune disorders, and infectious diseases. For more information, please visit its website at www.everestmedicines.com.
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