Pfizer Inc. announced that the European Commission has approved VELSIPITY® (etrasimod) for the treatment of patients aged 16 and over with moderately to severely active ulcerative colitis (UC) in the European Union, including Iceland, Liechtenstein, and Norway. This approval is for those inadequate to conventional therapy or a biological agent.
Leading expert Séverine Vermeire, MD, PhD, has welcomed this approval, highlighting the debilitating impact of UC on 2.6 million Europeans and the need for effective treatment options beyond injectables.
The approval follows the positive opinion issued by the EMA’s CHMP in December 2023, along with prior approvals from the FDA in October 2023 and Health Canada in January 2024. Pfizer has submitted further regulatory applications for VELSIPITY internationally. Alexandre de Germay, Chief International Commercial Officer at Pfizer, praised VELSIPITY’s oral dosing and benefit-risk profile, marking it as a promising treatment option for eligible UC patients.
VELSIPITY’s approval was supported by successful results from the ELEVATE UC Phase 3 registrational program. The program’s trials, ELEVATE UC 52 and ELEVATE UC 12, included patients with isolated proctitis and demonstrated that VELSIPITY improved clinical remission rates in UC patients with prior therapy failures or intolerances. The studies saw VELSIPITY reach all primary and key secondary efficacy endpoints while maintaining a favorable safety profile, including improved health-related quality of life measures. The most common adverse reactions were lymphopenia and headache.
This approval introduces VELSIPITY as an advanced therapy option for UC that addresses remission and targets an unmet medical need within the immune-mediated inflammatory bowel disease space.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
