Approvals

Pfizer has announced that the European Commission (EC) has granted marketing authorisation for Velsipity (etrasimod) in the European Union (EU). The drug is approved for the treatment of patients over the age of 16 with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to conventional therapy or a biological agent.

Themarketingauthorisationisvalidinall27EU member states, as well as Iceland, Liechtenstein and Norway. The approval follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use’s (CHMP) recommendation in December 2023.

The approval follows results from the ELEVATE UC phase 3 registrational programme (ELEVATE UC 52 and ELEVATE UC 12), which assessed the safety and efficacy of Velsipity 2mg once-daily on clinical remission in UC patients who had either previously failed or were intolerant to at least one conventional, biologic or Janus Kinase (JAK) inhibitor therapy. Both studies met all of their primary and secondary endpoints and demonstrated a positive safety profile.

Séverine Vermeire MD PhD, professor of medicine at KU Leuven, Belgium, and an investigator in the ELEVATE Registrational Programme, commented: “For the 2.6 million peopleinEuropelivingwithUC,theunpredictable 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. 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.”

Alexandre de Germay, chief international commercial officer, executive vice president at Pfizer, added: “Velsipity can help appropriate patients with UC who are struggling to achieve remission on conventional therapies. With convenient, once-daily oral dosing and a favourable 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.”