The European Medicines Agency (EMA) has agreed to review its marketing application for Amarin’s cardiovascular (CV) drug, Vascepa (icosapent ethyl).
The regulatory organisation says that it is expected to complete the review for the drug by the end of 2020, for the indication of reducing the risk of CV events in high-risk patients who have their cholesterol levels controlled with statins, but have elevated triglycerides and other CV risk factors.
The fish oil-derived therapy is already approved in the US for patients with severe hypertriglyceridaemia, with Amarin says it is also looking to add CV-risk lowering to the label based on results from the REDUCE-IT outcomes trial.
The Irish company’s chief executive officer reminded that if approved, the drug could become “the first and only EMA-approved, non-LDL-lowering agent with a CV-disease risk-reduction indication as an adjunct to statin therapy in dyslipidaemic patients in Europe.”
Amarin initially announced that it was to seek European approval for the medicine in May this year.
Cardiovascular diseases are the number one cause of death world-wide, with an estimated 17.9 million death attributed to them each year.