FDA Approves Fish-OIl-Based Drug To Cut Cardiovascular Risk

The stock for biotech Amarin surged in a late session on Friday after US regulators approved its fish-oil-based Vascepa as a means to reduce proficiency of cardiovascular events in patients who have high triglycerides.  

Before the announcement of the approval, traders had halted all action for Amarin, but the good news went through the trading floor like a shockwave.  After the announcement, Amarin shares soared more than 11 percent—to nearly 27—in extended action. 

Dr. John Sharretts explains that this is the very first FDA-approved medicine designed to lower the risk of traumatic events like heart attack and stroke among patients with high triglyceride levels. The approval is for patients found to have triglyceride levels of 150 mg per deciliter [of blood] or higher.  

The acting deputy director of the FDA Center for Drug Evaluation and Research Division of Metabolism and Endocrinology goes on to say, “The FDA recognizes there is a need for additional medical treatments for cardiovascular disease.  Today’s approval will give patients with elevated triglycerides and other important risk factors, including heart disease, stroke, and diabetes, adjunctive treatment option that can help decrease their risk of cardiovascular events.”

If this seems familiar, you might be recalling that Vascepa was originally only approved for the purpose of lowering triglycerides.  This approval, then, is for prescribing Vascepa for another use, and for good reason:  studies show that Vascepa can potentially reduce risk of cardiovascular event by as much as 25 percent.

This is great news for heart patients, particularly in the United States, where heart disease affects approximately 121 million adults, accounting for about one-third of all deaths.  Furthermore health care for these patients can range upwards of $500 billion, annually (in all), according to the American Heart Association.  The data also shows that several million Americans take non-prescription fish oil supplements—you may know them as Omega-3 fatty acids, as well—for heart health but these are believed to be not as potent as Vascepa.