NEW YORK CITY (dpa-AFX) - The European Commission has approved Pfizer's (PFE) Velsipity or etrasimod for the treatment of patients 16 years of age and older with moderately to severely active ulcerative colitis or UC who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological agent.
The approval is valid in all 27 European Union member states as well as Iceland, Liechtenstein, and Norway.
The authorization follows the recommendation for approval by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2023. It also follows VELSIPITY's approval for adults with moderately to severely active UC by the U.S. Food and Drug Administration (FDA) in October 2023, and for adults with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional therapy or an advanced treatment in Canada in January 2024. Regulatory applications for Velsipity in UC have been submitted to additional countries around the world for review.
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