Amarin, the US-based Irish drug development business, said the European Medicines Agency has accepted an application to licence its cardiovascular drug for the European market.
The agency will review the highly purified fish oil drug, called Vascepa, which has recently been recommended for wider market approval by a Food and Drug Administration panel. A final US decision is expected shortly. The European agency review is likely to conclude towards the end of 2020.
Vascepa has been found in trials to reduce the risk of cardiovascular events in high-risk patients who are already being treated with statins. These are patients who have high levels of a harmful blood fat called triglycerides.
Shares in Amarin climbed modestly on the news.
"The prevalence in Europe of people with persistent cardiovascular risk beyond standard of care statin therapy is high, like it is in most of the world," said Amarin chief executive John Thero.
The company said a recent survey showed about 25 per cent of a representative sample survey of more than 7,800 patients from 27 European countries with coronary heart disease and controlled LDL-cholesterol levels had elevated triglycerides levels.