Pfizer has obtained marketing authorisation from the European Commission (EC) for the oral sphingosine 1-phosphate receptor modulator VELSIPITY (etrasimod) to treat individuals aged 16 years and above with moderately to severely active ulcerative colitis (UC).
The approval in the EU is for UC patients who have not responded adequately to standard treatment or a biological agent, or are intolerant to these treatments.
The authorisation extends across all 27 member states and also includes Liechtenstein, Norway and Iceland.
In December 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approving VELSIPITY.
The latest decision was based on findings from the ELEVATE UC Phase III programme, comprising the ELEVATE UC 52 and ELEVATE UC 12 trials.
The programme assessed the efficacy and safety of a 2mg once-a-day dose of VELSIPITY on clinical remission in UC patients.
The therapy demonstrated significant improvements in study subjects.
It also met all primary and key secondary efficacy endpoints and exhibited a safety profile consistent with prior studies.
VELSIPITY showed an enhancement in the total inflammatory bowel disease questionnaire score, indicating improved health-related quality of life for patients.
The most common adverse reactions reported were lymphopenia, affecting 11% of patients, and headache, affecting 7%.
VELSIPITY received approval from the US Food and Drug Administration in October 2023 and in Canada in January 2024 for adult patients with moderately to severely active UC.
Pfizer chief international commercial officer and executive vice-president Alexandre de Germay stated: “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 in the EU.”
In February 2024, Pfizer expanded its multi-year agreement with Saama, intensifying efforts to expedite clinical research.
