A panel of experts to the U.S. FDA recommended allowing Amarin Corp Plc's fish-oil derived drug to be used as an add-on therapy for reducing the chance of heart attacks and strokes in high-risk patients with cardiovascular disease.
The panel on Thursday voted 16-0 in favor of expanding approval, potentially opening up a multi-billion dollar opportunity for Amarin which has only one drug, Vascepa, in the market.
Vascepa, a highly purified form of omega-3 fatty acid, won U.S. approval in 2012 to lower high levels of triglycerides.
"There is no doubt this is a medication that could benefit a substantial portion of the U.S. and meets an unmet need," said panel member Dr. Jack Yanovski of the National Institutes of Health.
The FDA, which has set a target date of Dec. 28 to decide on the label expansion, is not mandated to follow the recommendation of the panel, but generally does.
A late-stage trial last year found Vascepa, when administered to patients on cholesterol-lowering drug statin, cut the combined rate of heart attacks, strokes and other cardiovascular events by 25% compared to a placebo.
The panel was largely in favor of an approval in patients with history of cardiovascular disease, but some members were unconvinced of the drug's effectiveness in reducing cardiac events in patients who have not had strokes or heart attacks, or any other such events.
Jefferies analyst Michael Yee said on Thursday, ahead of the vote, that patients with existing cardiovascular disease would be the vast majority of those likely to be using Vascepa.
"Frankly it's not clear that the exact wording of the label would even materially impact prescriptions, utilization, or reimbursement," Yee added.
Some patients in the trial reported slightly higher risk of bleeding and a small increase in irregular heart rhythm, safety concerns that panel members suggested highlighting on the drug's label.
In the United States, cardiovascular disease leads to one in every three deaths. An expanded label could open up market access to up to 15 million Americans with high triglycerides and other cardiovascular risk factors, despite being on statin treatment.
Roth Capital Partners analyst Yasmeen Rahimi, who expects Vascepa to be a game changer in the cardiovascular market, sees it capturing about 12.1% of the market over the next decade, resulting in peak sales of $3.2 billion by 2030.
Amarin, whose shares were halted ahead of the panel vote, recorded revenue of $229.2 million last year. (Reuters)