(Bloomberg) -- Amarin Corp. won an expanded U.S. approval for its cardiovascular drug Vascepa, opening the market for the fish-oil based therapy to potentially millions more patients and giving the company a likely potent moneymaker.
The Food and Drug Administration said on Friday it had approved the drug as a secondary therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels, which can play a role in hardening the arteries. Vascepa’s active ingredient is the omega-3 fatty acid derived from fish oil.
“Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease,” the agency said in a statement. “Patients are advised to continue physical activity and maintain a healthy diet.”
Vascepa was first approved in 2012 as a treatment for people with severely high levels of triglycerides, a type of fat, in their blood. Analysts at SVB Leerink estimated that the new approval could increase the therapy’s potential patient population to 10 million, from about 600,000 currently.
Amarin shares were halted on Friday afternoon ahead of the announcement. To that point, the stock had surged some 77% this year.
“The FDA recognizes there is a need for additional medical treatments for cardiovascular disease,” said John Sharretts, acting deputy director of the division of metabolism and endocrinology products in the agency’s Center for Drug Evaluation and Research.
The approval had been widely expected. In November, all 16 members of an FDA advisory panel supported selling the drug for reducing the risk of cardiovascular events such as heart attacks and strokes, agreeing that Vascepa was both safe and effective.
The FDA has recently been pushing as hard as it can to get promising new therapies to more patients. On Thursday, it approved a Sarepta Therapeutics Inc. muscular dystrophy drug it had declined to clear only a few months earlier. In October, a Vertex Therapeutics Inc. treatment for cystic fibrosis gained approval months earlier than anticipated. The agency’s speed has jolted investors, helping drive up stocks of companies with drugs expected to get a ruling from regulators in the nearer-term.
Additionally, more therapies are moving along the agency’s fast-approval path, a development that could hasten the delivery of new drugs to patients with unmet medical needs. But some critics worry that could cause medicines that haven’t been thoroughly vetted to end up in American medicine cabinets, with unknown effects on patients’ health.
Vascepa could become a blockbuster, analysts on Wall Street believe, with some estimates placing peak annual sales at about $4 billion. That could make Amarin an appealing takeover target for a larger drug company looking to expand its offerings of heart drugs. Some global drugmakers are already making such bets. In November, Novartis AG snapped up Medicines Co., the New Jersey-based maker of an experimental cholesterol therapy some analysts have estimated could be a big seller if approved.
Not all big pharmaceutical companies see a significant future in heart medicines, however. Sanofi this week said it would move away from cardiovascular and diabetes drugs to focus on developing new cancer treatments. And Pfizer Inc., maker of the juggernaut cholesterol therapy Lipitor, is also focusing more on oncology medicines.
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