The National Institute for Health and Care Excellence (NICE) has recommended icosapent ethyl also called Vazkepa manufactured by Amarin for adults who have cardiovascular disease with controlled LDL-C levels taking a statin.
It's final draft guidance is expected to be available on the July 20.
Nearly half a million people are expected to benefit from the first licensed treatment shown to reduce the risk of heart attacks and strokes in people with controlled low-density lipoprotein cholesterol (LDL-C – sometimes called “bad” cholesterol) who are taking a statin and who have raised levels of triglycerides.
NICE said: “Clinical trial evidence suggests that for people with raised triglycerides who have LDL-C levels controlled by statins, and who have cardiovascular disease, icosapent ethyl reduces their risk of cardiovascular events by over a quarter compared with placebo.
Helen Knight, interim director of medicines evaluation at NICE, said: “Icosapent ethyl is the first licensed treatment of its kind for people who are at risk of heart attacks and strokes despite well controlled LDL cholesterol because they have raised blood fats. And although lifestyle changes, including diet and exercise, can help to reduce their risk, these may not work for everyone.
“We have worked closely with the company to identify the population most likely to gain the greatest benefit from icosapent ethyl, striking a balance between effectiveness and the best use of public funding, delivering maximum value to the taxpayer.”
Amarin’s Senior Vice President & President of Europe, Laurent Abuaf, said: “Vazkepa offers an important scientific innovation for patients with CVD, and the results of the REDUCE-IT trial demonstrate the benefits of its use for optimising the outcomes of patients at high risk of CV events, on top of treatments for traditional risk factors.
NICE’s recommendation will help to reduce the risk of CV events amongst a significant number of patients across England and Wales, and we are committed to working with all relevant stakeholders in the NHS to offer this important new treatment option to patients with CVD.”
Sukhi Basra