Pfizers Velsipity receives MHRA and NICE authorisations to treat ulcerative colitis – PMLiVE

Pfizers once-daily S1P receptor modulator Velsipity (etrasimod) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat moderately-to-severely active ulcerative colitis (UC).

The drug has been concurrently recommended by the National Institute for Health and Care Excellence (NICE) for use in patients aged 16 years and older who have had an inadequate response, lost response or been intolerant to conventional therapy or biological treatment.

Affecting approximately 300,000 people in the UK, 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.

NICE estimates that over 25,000 people in England will be eligible to receive Velsipity, which reduces inflammation in the colon by helping to control the level of immune cells in the blood.

The authorisations for the drug were supported by positive results from the late-stage ELEVATE UC registrational programme, which involved 743 patients aged 16 years and over for whom standard treatment or other treatments did not work well enough or could not be used.

Taken together, the results from the ELEVATE UC 52 and ELEVATE UC 12 studies showed that 26% of Velsipity-treated patients had achieved clinical remission compared with 11% of those who received placebo after 12 weeks of treatment.

One of the studies also looked at the longer-term effect of treatment and found that 32% of patients in the Velsipity cohort achieved clinical remission after 52 weeks, compared with 7% for those receiving placebo.

Helen Knight, director of medicines evaluation at NICE, said: Severe UC is a debilitating lifelong condition; [Velsipity] provides a new convenient and effective treatment option that will make a positive difference for thousands of people.

Im very pleased we have been able to publish our final guidance recommending the treatment on the day the MHRA granted it a licence.

Pfizer gained access to Velsipity through its $6.7bn acquisition of Arena Pharmaceuticals, which was finalised in 2022.

We are excited to add the impressive experience and pipeline of Arena to Pfizers inflammation and immunology therapeutic area, helping us further our purpose of developing breakthroughs to change the lives of those with immuno-inflammatory diseases, said Mike Gladstone, the then global president and general manager, Pfizer inflammation and immunology, when the buyout was finalised.

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Pfizers Velsipity receives MHRA and NICE authorisations to treat ulcerative colitis - PMLiVE