Amarin Corp stock lost over half its value on Wednesday in early trading after it failed to secure the backing of a panel of advisers in the U.S. to expand the use of Vascepa its fish-oil pill for people with blood that has high levels of fat.
Amarin’s American value fell by 62% to just $1.97. The company has seen its valued fall by 54% over the past 12 months, prior to this plunge. On Thursday, trading was stopped during the meeting of the advisory panel.
The U.S. Food and Drug Administration panel gave a vote of 9-2 on Wednesday that the company should conduct a study on the ability of the drug to benefit the heart prior to an approval decision for people who have triglycerides that are high. The U.S. FDA will decide if the drug will be approved for wider use on or before December 20.
The U.S. regulatory agency is not required to follow the advice of the panel. The FDA approved the prescription form last year of the omega-3 fatty acid to treat people with extremely high triglycerides.
The expanded approval would give Amarin, based in Dublin, Ireland access to a potential customer base in the U.S. of 36 million people, who currently have triglycerides that are high.
The FDA questions on October 11 whether the lipid lowering effects of Vascepa were sufficient enough to move ahead with the process of approval based on the clinical trials that failed to give a confirmation that the heart benefited from the lowering of the lipids.
Cholesterol and triglycerides are separate forms of lipids or fat that is in the blood.
Amarin, run from New Jersey, declined by 20% on October 11 following the release of the report, the largest drop the company had experienced in over three years.