Dublin-based Amarin Corp. PLC's expects a delay in the U.S. Food and Drug Administration's decision over the company's application for expanded use of Vascepa.
The regulator plans to hold an advisory committee meeting Nov. 14 in connection with its review of the application.
Amarin is looking to add a new indication for Vascepa, or icosapent ethyl, based on results from a study called Reduce-It, which showed the prescription-only treatment successfully cut the risk of heart-related events such as heart attacks and stroke in certain patients.
The company said it did not receive an update from the FDA regarding the possible extension of the review period. However, based on the date of the advisory committee meeting, it expects a decision on its application in late December instead of the previously expected date of Sept. 28.
In May, the company was granted a priority review designation for Vascepa to treat heart patients who are already on statin therapy to control LDL-C cholesterol and have high levels of triglycerides. The FDA's priority review period is usually six months.
The company intends to move forward with its plans to double the size of its sales force to support the launch of Vascepa and plans to use the anticipated three-month delay to better prepare for the assumed launch of Vascepa, including more time to hire and train new sales representatives.
Amarin's shares were down 21.56% to $14 in after-hours trading Aug. 8.