Amarin Corporation plc (NASDAQ:AMRN) was barred from trading at the NASDAQ exchange till the company comes clean for its new fish—oil drug Vascepa. While AMRN has requested the US FDA body to approve the marketing of its new product, the FDA has dispatched a special committee to review this request even as the company waits.
This biopharmaceutical company has hopes that the FDA will approve further expansion of its fish-oil drug Vascepa for use by heart patients. The drug is used mostly for hyperglyceridemic patients to help them lower the levels of triglycerides from their blood. The FDA approval for the drug also states that it was approved to be used for hyperglyceridemic patients only. It is expected that the FDA’s special committee known as the Endocrinologic and Metabolic Drugs Advisory Committee will meet soon and take action on this matter.
It is hoped that the FDA will release its direct verdict on the expansion of the use of this drug by the end of this year. For this particular assessment the FDA is looking at the ability of this drug to provide any noticeable comfort to heart patients although there have been several studies which indicate that triglyceride levels are brought down by as much as 20%. Recent studies by different sources have however revealed that the lowering of triglyceride levels and cholesterol levels don’t really have much of an impact when it comes to heart and heart related diseases. This could very well turn out to be bad news for the company and Vascepa as the company may have to wait for a little longer to get the results that it wants to be able to widen the scope of Vascepa. The current share values for Amarin Corporation stand at $5.17.
