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

2024-02-21

上市批准临床结果并购免疫疗法

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

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来源: PMLiVE

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 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, Pfizer said.

Alexandre de Germay, chief international commercial officer, executive vice president at Pfizer, 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 EU.”

The approval comes just a few months after Velsipity was approved by the US Food and Drug Administration to treat adult UC patients. Regulatory applications have also been submitted for the drug in additional countries, including the UK.

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 Pfizer’s 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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