Pfizer Inc. is thrilled to announce that VELSIPITY® (etrasimod), the first oral therapy of its kind for ulcerative colitis (UC), has received marketing authorization from the European Commission for patients aged 16 and older. This approval marks a significant milestone in the treatment of moderately to severely active ulcerative colitis for those who have not found success with conventional therapy or biological agents.
For the approximately 2.6 million individuals in Europe grappling with UC, the journey through various treatments to find symptom relief can be challenging. The condition’s unpredictable nature affects patients not just physically but also mentally and emotionally. VELSIPITY’s approval offers new hope, particularly for those seeking an effective alternative to injectable therapies. According to Séverine Vermeire, MD, PhD, Professor of Medicine at KU Leuven and an investigator in the ELEVATE Registrational Program, VELSIPITY bridges a crucial gap, providing a much-needed oral advanced treatment option.
VELSIPITY’s authorization extends across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway, following a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use. This follows its approval in the U.S. by the FDA and in Canada for adults with similar conditions. VELSIPITY is currently under review in several other countries worldwide.
Charting a New Course in Ulcerative Colitis Treatment with European Approval
Alexandre de Germay, Pfizer’s Chief International Commercial Officer, highlighted VELSIPITY’s benefits, noting its once-daily oral dosing and favorable benefit-risk profile. The drug’s ease of use and effectiveness make it a compelling treatment option for UC patients as young as 16 in the European Union. The approval was based on the ELEVATE UC Phase 3 registrational program, which showed VELSIPITY’s efficacy in achieving clinical remission in patients who had previously not responded to or were intolerant to other therapies, including biologics and JAK inhibitors. Notably, the studies also included patients with isolated proctitis, a condition affecting about 30% of UC patients, demonstrating VELSIPITY’s broad potential impact.
Ulcerative colitis is a chronic, immune-mediated inflammatory bowel disease characterized by inflammation of the mucosal lining of the colon and rectum. Symptoms can range from diarrhea and abdominal pain to fatigue and anemia, profoundly impacting patients’ quality of life. VELSIPITY, as a selective sphingosine-1-phosphate (S1P) receptor modulator, offers a novel mechanism of action, binding selectively with receptor subtypes involved in the pathogenesis of UC. This approval opens the door for further applications of VELSIPITY in ulcerative colitis across additional countries, including Australia, India, and the UK, among others.
Resource : Biospace, February 19, 2024
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