Pfizer’s Velsipity granted EC approval for ulcerative colitis in patients aged from 16 years

The immune-mediated inflammatory bowel disease affects approximately 2.6 million people in Europe. Pfizer’s S1P receptor modulator Velsipity (etrasimod) has been approved by the European Commission (EC) to treat moderately-to-severely active ulcerative colitis (UC) in patients aged 16 years and older.

Those eligible for the drug, which is now the first and only oral advanced UC therapy approved in the EU for this patient population, will have had an inadequate response, lost response or been intolerant to conventional therapy or a biological agent.

Affecting approximately 2.6 million people in Europe, UC is a chronic, immune-mediated condition where the colon and rectum become inflamed, causing symptoms such as frequent diarrhoea, bowel urgency, rectal bleeding, abdominal pain, fatigue, fever and anaemia.

The EC's decision on Velsipity follows a recommendation from the European Medicines Agency’s human medicines committee in December and was supported by positive results from the late-stage ELEVATE UC registrational programme.

The ELEVATE UC 52 and ELEVATE UC 12 studies, which evaluated Velsipity 2mg once-daily on clinical remission in UC patients who had previously failed or were intolerant to at least one conventional, biologic or JAK inhibitor therapy, achieved all primary and key secondary efficacy endpoints and demonstrated a favourable safety profile consistent with previous studies of the drug.

Velsipity also demonstrated improvements in the total inflammatory bowel disease questionnaire score, which measures health-related quality of life.

February 23, 2024