Amarin’s Vazkepa (icosapent ethyl) has been recommended by the National Institute for Health and Care Excellence (NICE) for adults receiving statin treatment who are deemed to be at high cardiovascular risk, have elevated triglycerides and diagnosed cardiovascular disease (CVD).
Vazkepa is a new active substance, made up of a highly purified omega-3 fatty acid and is the first in this class to be issued a NICE recommendation for CV risk reduction. Having been granted this recommendation, Vazkepa could potentially benefit over one million people living in England who have been placed at high risk of a subsequent CV episode, eg a second heart attack.
In England, more than six million people live with CVD, which costs the NHS an estimated £7.4bn per year. While available treatments have helped in reducing the risk of future CV events, more than 137,000 people continue to die from CVD every year.
For certain patients, a considerable future risk remains, with one in three suffering from a subsequent CV event within seven years after their first heart attack.
Vazkepa is an innovation for patients deemed at risk of CV in England, as data from the pivotal double-blind, randomised REDUCE-IT phase 2 clinical trial showed.
More than 8,000 patients over an average of 4.9 years treated with Vazkepa compared to placebo experienced a 25% relative reduction in the risk of future major CV events. These events include a composite of CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation or hospitalisation for angina.
The final guidance for Vazkepa is expected to be made public on 20 July 2022.
Amarin’s senior vice president and president of Europe, Laurent Abuaf, said: “Vazkepa offers an important scientific innovation for patients with CVD. 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 among a significant number of patients across England and Wales, and we are committed to working with the NHS to offer this important new treatment option to patients with CVD.”