The European Commission (EC) has granted regulatory approval to Pfizer (NYSE: PFE) for its S1P receptor modulator Velsipity (etrasimod) as a treatment for patients aged 16 and older with moderately to severely active ulcerative colitis (UC). The approval applies to patients who have had an inadequate response, lost response, or were intolerant to previous therapies. This decision is supported by late-stage clinical data demonstrating that the daily pill not only improves the quality of life for patients but also exhibits a favorable benefit-risk profile.
The announcement was made by China-based partner Everest Medicines (HKG: 1952), which is currently conducting a Phase III trial for Velsipity and plans to file the drug for review in China this year. This marks a significant expansion of the drug’s potential market, as it is already approved in Canada and the US.
The approval by the European Commission underscores the growing global recognition of Velsipity as an effective treatment option for patients with ulcerative colitis and highlights the potential for broader access to this therapy across Europe.- Flcube.com
