Shares of troubled drugmaker Amarin fell again Friday after the Food and Drug Administration refused to reconsider a recent decision that casts doubt on the future of the company's lead product.
THE SPARK: The Irish drugmaker said in a regulatory filing that the FDA refused to consider the company's appeal of an Oct. 29 decision to terminate an agreement that would have expanded approval of Amarin's drug Vascepa if the company showed it lowered triglycerides, a type of fat in the bloodstream. The FDA said that it no longer considers a change in triglyceride levels enough to establish the effectiveness of a drug that aims to reduce the risk of cardiovascular problems like heart attacks in certain patients. The agency also rejected Amarin's request for a meeting with a high-level official to discuss the appeal.
THE BACKGROUND: Amarin's only product is the pill Vascepa, a prescription-strength form of an omega-3 fatty acid found in fish oil. Regulators approved the drug in 2012 for a relatively narrow use in patients with unusually high triglyceride levels.
The drugmaker is currently seeking FDA approval to market the drug for an expanded use in patients with high triglyceride levels and heart disease who are already taking a statin drug to help control their cholesterol.
The FDA told Amarin last month that clinical research results do not support the hypothesis that a triglyceride-lowering drug significantly reduces the risk for heart problems in these patients.
A panel of outside advisers to the FDA had already voted against recommending the broader use in mid-October. Shares have been sliding since the vote was announced. A final FDA decision on Vascepa is expected by Dec. 20.
THE ANALYSIS: Citi analyst Jonathan Eckard said FDA's rejection of the company's request was expected. Eckard maintains a "Buy" rating on the stock with a target price of $2.50 based on Vascepa's current sales. He does not expect the drug to win expanded approval for patients with heart disease.
SHARE ACTION: Shares of Amarin Corp. PLC fell 23 cents, or 11.5 percent, to $1.76.
- Health Care Industry
- Food and Drug Administration