Everest Medicines, in collaboration with Pfizer Inc., announced a significant development for patients with ulcerative colitis in the European Union. The European Commission has approved VELSIPITY® (etrasimod) for patients aged 16 and older with moderately to severely active ulcerative colitis who have not responded well to conventional therapy or a biological agent. This approval makes VELSIPITY the first and only oral advanced therapy for this age group in the EU, providing a new, once-daily treatment option.

Rogers Yongqing Luo, CEO of Everest Medicines, expressed congratulations to Pfizer for this achievement and highlighted the importance of this approval for patients seeking remission from conventional therapies. Everest Medicines is also advancing its Phase 3 study in Asia and plans to submit a New Drug Application in Greater China within the year, responding to the rapidly increasing incidence of ulcerative colitis in the region.

VELSIPITY's approval is part of a broader global initiative, following its endorsement by the U.S. FDA and Canadian health authorities for adults with moderately to severely active ulcerative colitis. This S1P receptor modulator offers a promising option for corticosteroid-free remission, mucosal healing, and rapid symptom relief. The approval was supported by the ELEVATE UC Phase 3 program, which demonstrated VELSIPITY's efficacy and safety, including in patients with isolated proctitis, a condition affecting about 30% of those diagnosed with UC.

VELSIPITY works by selectively binding with specific S1P receptor subtypes, offering a novel mechanism of action in the treatment of ulcerative colitis. This milestone not only broadens the treatment landscape for patients in the EU but also sets the stage for further approvals in Asia and other regions, underscoring the global need for effective ulcerative colitis therapies