Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for VELSIPITY (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.

“For the 2.6 million people in Europe living with UC, the unpredictable physical, mental, and emotional impacts of the condition can be debilitating. They may cycle through several different conventional treatment options to find relief for their symptoms,” said Séverine Vermeire, MD, PhD, Professor of Medicine at KU Leuven and an investigator in the ELEVATE Registrational Program. “The approval of VELSIPITY helps bridge the gap for those with moderately to severely active UC who need an effective advanced treatment but may be apprehensive about using injectable therapies like biologics.”

The marketing authorization for VELSIPITY is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway. This authorization follows the recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2023.

“VELSIPITY can help appropriate patients with UC who are struggling to achieve remission on conventional therapies,” said Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer. “With convenient, once-daily oral dosing and a favorable benefit-risk profile, VELSIPITY is an attractive potential treatment option and Pfizer is proud to bring this medicine to appropriate UC patients as young as 16 years old in the European Union.”

The approval was based on results from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12) that evaluated the safety and efficacy of VELSIPITY 2 mg once-daily on clinical remission in UC patients who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy.