Boston, MA 10/17/2013 (wallstreetpr) – Amarin Corporation plc (ADR) (NASDAQ:AMRN) has requested the United States Food and Drug Administration to approve further marketing of its new fish-oil drug, Vascepa. A special FDA committee is on its way to review the request. Meanwhile, NASDAQ exchange has halted the company’s shares trading till the company comes out clean.
The late-stage biopharmaceutical company wishes to expand the approved uses of its fish-oil drug, Vascepa especially designed for the hyperglyceridemic patients to lower triglycerides from their blood stream. The use of Vascepa was first approved by the FDA in July 2012 only for the patients with very high triglyceride levels but the company wants to expand its uses to heart-disease patients already taking statin drug to lower their cholesterol. To discuss on the expanded use of the drug with Amarin, the FDA’s special Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to meet today.
By the end of this year, the FDA will give its verdict on the further expansion of Vascepa. Though the committee is supposed to take advices from the advisory panels, the scenario is different for this assessment. According to the FDA, Vascepa has the efficiency to lower the triglyceride levels by more than 20% but the researchers are not sure whether this reduction of the levels in the heart patients will result in real benefits for them or not. Many scientists have pointed to some recent studies that show reduction in triglyceride and cholesterol levels does not really contribute to the heart related diseases. These studies by the scientists have actually changed the minds of the committee members to approve Amarin to expand Vascepa for heart patients. Amarin may have to wait for some years until positive results are obtained by the reviewers. Amarin shares are currently trading at $5.17.
