Amarin announced Monday that the European Medicines Agency (EMA) has agreed to review its marketing application for Vascepa (icosapent ethyl) as a treatment to reduce the risk of cardiovascular (CV) events in high-risk patients who have their cholesterol levels controlled with statins, but have elevated triglycerides and other CV risk factors. The EMA is expected to complete its review for the fish-oil-derived drug, which is currently not available in Europe for any indication, before the end of 2020.
Vascepa is already approved in the US for patients with severe hypertriglyceridaemia, with Amarin also looking to add CV-risk lowering to the label based on results from the REDUCE-IT outcomes trial. An FDA advisory panel unanimously backed the broader indication last month, and the US regulator is expected to render a decision by December 28.
Amarin CEO John Thero said the company is also basing its European filing on the REDUCE-IT trial. The study has been under scrutiny over the decision to use a mineral-oil placebo, which some suggested might have skewed the results in Amarin's favour, although a recent FDA staff report minimised any potential role it might have played. However, agency reviewers did point out certain safety signals, including higher rates of atrial fibrillation/flutter and bleeding among Vascepa-treated patients in the trial.
Thero noted that if approved, Vascepa "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 cited results from a recent survey indicating that about 25% of a sample of more than 7800 patients across Europe with coronary heart disease and controlled LDL-cholesterol levels had triglyceride levels over 150 mg/dL, highlighting the "potential pervasiveness of high-risk cardiovascular disease in Europe beyond currently available therapies."
For additional analysis, see Pharma Leaders: Amarin CEO John Thero. Read also, ViewPoints: Amarin clinches preliminary FDA victory.
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