The European Commission granted marketing authorization in the EU to treat patients 16 years of age and older with moderately to severely active ulcerative colitis.
Pictured: Pfizer building in San Francisco, California/iStock, hapabapa
Pfizer announced on Monday its ulcerative colitis drug Velsipity has secured the European Commission’s marketing authorization to treat patients over 16 years of age with moderately to severely active ulcerative colitis.
The approval from the European Commission gives the drug authorization in all EU member states as well as Norway, Iceland, and Liechtenstein. Velsipity was recommended for approval by the EMA in December 2023. It was also approved in Canada in January 2024.
“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,” Séverine Vermeire, professor of medicine at KU Leuven and an investigator in the Elevate Registrational Program, said in a statement.
According to Pfizer, the European approval is based on results from its Elevate UC Phase III program, which not only met its endpoints but also showed improvement in the total inflammatory bowel disease questionnaire score, which was used to determine health-related quality of life.
In Velsipity’s Elevate 52 trial, 27% of patients reached clinical remission compared to 7% on a placebo at week 52. In the other trial, Elevate 12, remission rates were 26% versus 15% for those taking a placebo.
The FDA approved Velsipity in October 2023 based on studies reaching their primary and secondary endpoints as well as favorable safety profile. The results investigating the drug were published in The Lancet in March 2023.
“Velsipity can help appropriate patients with UC who are struggling to achieve remission on conventional therapies,” Alexandre de Germay, chief international commercial officer at Pfizer, said in a statement. “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.”
Biotech AltruBio is also working on an ulcerative colitis treatment and started enrollment in a Phase II trial for its asset.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
