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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 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.

PfizereliS1P receptor modulatoriVelsipity (etrasimod)nd only oral advanced UC therapy approved in the EU for this patient population, wiactive ulcerative colitis (UC)onse, 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 resulfrequent diarrhoeatage ELEVATE UC registrational proabdominal pain fatigue fever anaemia

The ELEVATE UC 52 andVelsipityUC 12 studies, which evaluated VelsEuropean Medicines Agencylinical 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 inflammVelsipityel disease questionnaire score, which measures health-related quality of life, Pfizer said.JAK inhibitor JAK

Velsipity de Germay, chief international commercial ofinflammatory bowel diseaseident at Pfizer, said: “Velsipity can help appropriate patients with Pfizer are struggling to achieve remission on conventional therapies.

“With convenient, once-daily oral dosing and a favourable benefit-risk profile, VelsipityPfizer 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 FoodVelsipity Administration to treat adult UC patients. RegulPfizerapplications have also been submitted for the drug in additional countries, including the UK.

Pfizer gained access to Velsipity through iVelsipity acquisition of Arena PhFood and Drug Administrationalised in 2022.

Pfizere excited to add tVelsipitysive experience and pipeline of AreArena Pharmaceuticalsmation 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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