Food Drug Administration Assessment Doesn’t Go Well For Amarin Corporation plc (ADR) (NASDAQ:AMRN)
On Friday, Food Drug Administration staffers posted their assessments of the application for Amarin Corporation plc (ADR) (NASDAQ:AMRN), on the agency’s official website. Some analysts averred that the review seemed more cautious than they had expected it to be.
Currently, Vascepa is approved as a standalone treatment in lowering high-levels of blood fats (triglycerides). These are known to raise heart disease risk. The company is also hoping to gain approval to market this drug for patients who suffer from blood-fat abnormalities and who are at a high risk of heart disease. These patients may already be treated with a statin like Lipitor that is manufactured by Pfizer. This is used to bring down cholesterol levels in the body.
A panel of advisors, outside the FDA will discuss the application that Amarin Corporation plc (ADR) (NASDAQ:AMRN) has put forth and decide whether it should be considered for approval, on Wednesday. The issue that stands is whether the FDA regulators will be satisfied with the data that indicates that the drug can lower triglyceride levels. There is a chance that they may demand for additional data from the ongoing-trial of 8,000 patients. This trial is expected to show whether the drug is able to cut the rate of cardiovascular-events and death.
In Friday’s trading, Amarin Corporation plc (ADR) (NASDAQ:AMRN) dropped by 20.09%. The shares opened at a price of $6.30, which rose to an intraday high of $7.15 and dropped to close at $5.09. Approximately 37.91 million shares were traded on Friday while an average volume of 6.84M shares were traded over a period of 30 days. The 52-week low of Amarin Corporation plc (ADR) (NASDAQ:AMRN) shares is $5.01 and its 52-week high is $12.96. Amarin Corporation plc (ADR) (NASDAQ:AMRN) has a market capitalization of $876.21 billion.