The EC approval of Velsipity was supported by results from the Phase 3 ELEVATE UC registrational programme, which includes ELEVATE UC 52 and ELEVATE UC 12 clinical trials that achieved all primary and key secondary efficacy endpoints
New Pfizer headquarters entrance. (Credit: Pfizer Inc.)
Pfizer has secured the European Commission (EC) marketing authorisation for Velsipity (etrasimod) in the European Union (EU) to treat a type of ulcerative colitis (UC).
Velsipity is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5.
The drug is indicated for patients aged 16 years and above with moderate to severe active ulcerative colitis (UC), who were intolerant to either conventional therapy or a biological agent.
The EC marketing authorisation for Velsipity is applicable in all 27 EU member states along with Iceland, Liechtenstein, and Norway.
Pfizer submitted regulatory applications for Velsipity to additional countries including Australia, India, Mexico, Russia, Singapore, Switzerland, Turkey, and the UK.
ELEVATE Registrational Program investigator Séverine Vermeire said: “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.
“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 EC authorisation 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 the US Food and Drug Administration (FDA) approval of Velsipity to treat adults with moderately to severely active UC in October 2023, and in Canada in January 2024.
The EC approval was supported by results from the Phase 3 ELEVATE UC registrational programme, which includes ELEVATE UC 52 and ELEVATE UC 12 clinical trials.
The programme evaluated the safety and efficacy of Velsipity in UC patients who had previously failed or were intolerant to at least one conventional or Janus kinase (JAK) inhibitor therapy.
Both studies achieved all primary and key secondary efficacy endpoints, with a favourable safety profile consistent with previous studies of Velsipity.
The drug also showed improvement in the total inflammatory bowel disease questionnaire score, which measures health-related quality of life.
The most common adverse reactions in the studies include lymphopenia and headache.
Pfizer executive vice president, chief international commercial officer Alexandre de Germay said: “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.”