The United States Food and Drug Administration (FDA) has approved a new indication and label expansion for Ireland-based Amarin Corporation plc's (NASDAQ: AMRN) VASCEPA (icosapent ethyl) capsules, it was reported on Friday.

The product is now the first and only drug approved by the US FDA 'as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularisation, and unstable angina requiring hospitalisation in adult patients with elevated triglyceride (TG) levels (more than 150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.'

The company reaffirmed its plans to launch VASCEPA in the United States for this important new preventative care indication. As earlier revealed, Amarin doubled the size of its sales force near the start of 2019 and is on track to double the size of its sales force again to a total of 800 sales representatives near the start of 2020.