Vascepa, a fish oil drug manufactured by Amarin Corp., may have an expanded use depending on the result of a heart risk study. An advisory panel from the U.S Food and Drug Administration is scheduled October 16 to meet with the representatives for the approval to begin the study trials.
The Dublin-based company is finding out Vascepa’s capacity to reduce cardiovascular events. The results of the study is said to be available in 2016.
Vascepa is the only product of Amarin. It was approved by the FDA in July 2012 and had been used by people with very high presence of triglycerides. The latter is a measure of fat in the blood which is said to be at 500 milligrams per deciliter. On December 20, the agency had to come out with a decision on whether to clear the drug for those with high triglycerides, a level of 200 to 500 milligrams per deciliter.
An expanded approval of Amarin would make the drug more accessible to 36 million potential users in the U.S with elevated triglycerides. The number is nine times the recorded number of people with severely high levels of triglyceride.
Forecasted sales of Vascepa may reach an average of $932 million by 2017 based on the estimates made by six analysts and compiled later on by Bloomberg.
Vascepa may be the first of its kind to gain approval for high triglycerides from the FDA. Compared to the fish oil pill Lovaza, Vascepa doesn’t raise the levels of bad cholesterol.
Stores such as Vitamin Shoppe Inc and GNC Holdings Inc sell dietary supplements containing fish oil without asking for a prescription. According to the company’s official Vascepa site, 10 to 40 omega 3 capsules are needed to match the pure fatty acid content of the wild deep-water fish from the Pacific Ocean.
Amarin is seeking the "new chemical entity" status which will enable the company to gain five years of exclusivity to retail the drug without having any generic competition. On the other hand, the FDA has published in April a draft to guide companies in creating their generic version of Vascepa should they become interested to do so.
