FDA expands Amarin's Vascepa label to include reducing persistent CV risk in certain patients

The FDA announced Friday that it has expanded the label for Amarin's fish-oil-derived drug Vascepa (icosapent ethyl) to include use as an adjunctive therapy to lower the risk of cardiovascular (CV) events in adults with triglyceride levels of 150 mg/dL or more. Patients must also have either established CV disease or diabetes and at least two additional risk factors for CV disease. 

The agency noted that Vascepa now becomes the first FDA-approved drug to reduce the risk of myocardial infarction, stroke, coronary revascularisation and unstable angina requiring hospitalisation among patients with elevated triglyceride levels, as an add-on to maximally tolerated statin therapy. The approval comes a month after an FDA advisory panel voted unanimously to back the drug based on data from the REDUCE-IT CV outcomes trial, in which Vascepa was associated with a 30% risk reduction in total major adverse CV events compared to placebo. 

Amarin CEO John Thero stated that the "expanded indication and related clinical study labeling is broadly worded, informative on the many effects of Vascepa and will empower physicians with critical information to help them apply their clinical judgment in addressing CV disease risk for patients." 

Vascepa has been approved in the US since 2012 for patients with severe hypertriglyceridaemia. The company, which estimates that "millions of people" in the country may now qualify for treatment with Vascepta under its expanded label, said it plans to promptly launch the drug for the new indication, noting that it already boosted its salesforce earlier this year and is on track to double it to a total of 800 sales representatives near the beginning of 2020. Analysts at SVB Leerink estimated that the new approval could increase the therapy's potential patient population to 10 million, from roughly 600,000 currently.

Amarin also boosted its revenue guidance for Vascepa to a range of $410 million to $425 million for 2019, compared with its most recent outlook of $380 million to $420 million. The company said its new guidance reflects a jump of about 82% over 2018 sales results. Meanwhile, 2020 revenues are predicted to be between $650 million to $700 million, mostly from sales of Vascepa in the US. Beyond 2020, Amarin believes that Vascepa's total net revenue will reach "multiple billions of dollars. However, the history of other therapies for chronic conditions suggests that growth builds over multiple years." Some analysts anticipate peak annual sales of about $4 billion for the drug.

Vascepa is currently under review in Europe as a potential treatment to reduce 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 European Medicines Agency is expected to complete its assessment for the drug, which is currently not available in Europe for any indication, before the end of 2020. 

For additional analysis, see Pharma Leaders: Amarin CEO John Thero. Read also, ViewPoints: Amarin clinches preliminary FDA victory.

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