(Reuters) - U.S. health regulators on Friday approved expanding the heart benefit claims Amarin Corp can make in promoting its drug Vascepa to include reducing the risk of heart attacks and strokes in high-risk patients, opening a multibillion-dollar market opportunity.
The decision comes a month after an independent panel of experts to the Food and Drug Administration voted unanimously in favor of allowing the broader claims based on positive clinical trial data.
Vascepa, a highly purified form of omega-3 fatty acid, won U.S. approval in 2012 to lower high triglycerides - a type of blood fat that can increase the risk of heart disease.
The expanded label allows the company to tap into a market of up to 15 million Americans at risk of developing cardiovascular complications despite being on statin treatment to lower cholesterol.
Roth Capital Partners expects Vascepa to capture about 12% of the U.S. market over the next decade, forecasting peak annual sales of $3.2 billion by 2030.
Vascepa has been heralded as a potential game changer in the cardiovascular disease market by Wall Street analysts.
In clinical trials, Vascepa cut the combined rate of heart attacks, strokes, heart-related death, need for artery-clearing procedures and hospitalizations for unstable angina by 25% compared to placebo. That comes on top of the heart attack risk reduction of about 25% patients already get from statins.
Heart disease is the leading cause of death in the United States. By 2035, 45% of the U.S. population is estimated to be diagnosed with some form of cardiovascular disease, resulting in annual treatment costs in excess of $1 trillion, according to The American Heart Association.
Vascepa has been highlighted as a cost-effective add-on to statins by the Institute for Clinical and Economic Review. The therapy’s annual cost based on list price of around $3,600 is much lower than the non-profit group’s recommended value-based price range of $6,300 to $9,200.
Insurers are expected to further embrace the pill now that the expanded heart benefit claim is official.
“Some have contracted and agreed in writing to improve their coverage, based upon approval and others have suggested that we contact them promptly after the approval,” Chief Executive Officer John Thero told Reuters ahead of the decision.
European health regulators are expected to announce a decision on Vascepa’s heart benefit claims before the end of 2020.
Reporting by Saumya Sibi Joseph and Manojna Maddipatla in Bengaluru; Editing by Bill Berkrot