Little more than a month after the FDA's Endocrinologic and Metabolic Drugs Advisory Committee unanimously supported approval of Amarin Corp. plc's fish oil-based Vascepa (icosapent ethyl) for reducing the risk of cardiovascular (CV) events in adults with elevated triglyceride levels, the agency has greenlighted a label expansion for the already-approved medicine, allowing for its adjunctive use in that indication. Patients must have blood triglyceride levels of 150 mg/dL or higher and either established CV disease or diabetes and two or more additional risk factors for cardiovascular disease, too. Vascepa was initially approved in 2012 for adults with severe triglyceride levels.

The decision, arriving nearly two weeks ahead of an assigned PDUFA date, makes Vascepa the first FDA-approved drug to reduce CV risk among patients with elevated triglyceride levels as an add-on to maximally tolerated statin therapy, the agency said. It follows a priority review.

Based on an analysis of federal and other data by Nathan Wong, a University of California, Irvine researcher supported in part by Amarin, 70.5 million U.S. adults have triglyceride levels of 135 mg/dL or higher, including 15.2 million of those being treated with statins.

"The FDA recognizes there is a need for additional medical treatments for cardiovascular disease," said John Sharretts, acting deputy director of the agency's division of metabolism and endocrinology products.

Vascepa's active ingredient is the omega-3 fatty acid, eicosapentaenoic acid, derived from fish oil. The drug's safety and efficacy were established in a study of 8,179 patients who were either 45 years and older with a documented history of coronary artery, cerebrovascular, carotid artery and peripheral artery disease, or 50 years and older with diabetes and additional risk factors for cardiovascular disease. Those who received Vascepa were significantly less likely to experience a CV event, such as a stroke or heart attack.

In the phase III REDUCE-IT (Reduction of Cardiovascular Events with EPA – Intervention Trial) study, Vascepa provided a 25% relative risk reduction compared to placebo in the first occurrence of a major adverse cardiovascular event and a statistically significant 30% risk reduction compared to placebo in the statin-treated patients in the intent-to-treat population.

Vascepa had sales of $228 million in 2018. It's expected to reach blockbuster status, with more than $1 billion in sales, by 2025, according to Cortellis. Amarin is now projecting that its total net revenue will be in a range of $650 million to $700 million, mostly from U.S.-based sales of Vascepa.

The wholesale acquisition cost for a 30-day supply of the 1-gram dose is $303.65, though insurance plans are likely to substantially lower patients’ out-of-pocket costs.

"Beyond 2020, Amarin believes that Vascepa total net revenue will grow to reach multiple billions of dollars," the company said. "However, the history of other therapies for chronic conditions suggests that growth builds over multiple years."

With the supplemental NDA approval squared away, analyst said that investor attention is now likely to turn to patent challenges from generic drugmakers seeking to invalidate Amarin’s patents. Heading into the trial, which is slated to start Jan. 13, 2020, “our analysis suggests that it is in both parties' interests to settle the case for a generic entry in the late 2020s,” SVB Leerink analyst Ami Fadia said.

Amarin's shares (NASDAQ:AMRN) fell $1.24 cents, or 5.1% to close at $22.88 on Monday.

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