Shares of Amarin Corp. (AMRN) were just halted.
Not long ago, a Food and Drug Administration committee said the company’ prescription fish-oil pill Vascepa has a “favorable benefit/risk profile” for a cardiovascular indication. Now, an FDA Advisory Committee will meet today to discuss the fish-derived cardiovascular drug.
At the moment, it’s approved to reduce triglycerides.
The company is now asking the FDA to extend the label so it can be prescribed to treat cardiovascular issues, such as heart attacks and strokes. If successful, this could lead to substantial opportunity for Amarin.
As reported by Barron’s, “SVB Leerink analyst Ami Fadia projects peak sales of more than $4 billion a year for Vascepa, if the label is expanded.”
Chart from StockCharts.com
Amarin Corp. engages in the development and commercialization of therapeutics for the treatment of cardiovascular diseases in the United States. The company’s lead product is Vascepa, a prescription-only omega-3 fatty acid capsule, used as an adjunct to diet for reducing triglyceride levels in adult patients with severe hypertriglyceridemia.
It is also involved in developing Vascepa for the treatment of patients with high triglyceride levels who are also on statin therapy for elevated low-density lipoprotein cholesterol levels. Amarin Corporation plc sells its products principally to wholesalers and specialty pharmacy providers.