The Food and Drug Administration on Friday expanded the approval of Vascepa, a fish-oil-derived medicine, to allow the drug’s maker to say it prevents heart attacks, strokes, and related health problems in people who are at high cardiovascular risk.
The approval reverses decades of mixed results for fish-oil-based drugs and could result in Vascepa being prescribed to millions of patients, potentially resulting in a windfall for the drug’s maker, Amarin (AMRN) Pharmaceuticals, which sells no other products.
But the FDA decided to limit the use of Vascepa more than Amarin had initially requested. Vascepa will be approved for patients who already have established cardiovascular disease — meaning they have had a problem like a heart attack or chest pain that appeared quickly — or for those who have diabetes and two risk factors for heart attacks. Vascepa is approved for use in patients who have levels of triglycerides, or particles of fat in the blood, that are above 150 milligrams per deciliter, slightly higher than the 135 mg/dL Amarin requested.
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“The FDA recognizes there is a need for additional medical treatments for cardiovascular disease,” Dr. John Sharretts, acting deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “Today’s approval will give patients with elevated triglycerides and other important risk factors, including heart disease, stroke and diabetes, an adjunctive treatment option that can help decrease their risk of cardiovascular events.”
Even with those limitations, usage of Vascepa could increase dramatically. Before the approval, results of a scientific study published last November have led Amarin’s sales in the third quarter of this year to double from a year ago to $112 million.
Vascepa’s expanded use was approved based on a study of 8,179 patients who were given either 4 grams of Vascepa daily — eight pills — or placebo on top of heart medicine. Those that got the pills had a 25% decrease in their risk of heart attacks, stroke, need for a stent, or sudden chest pain — all the outcomes were lumped together for statistical power.
In that clinical trial, Vascepa was associated with a slightly increased risk of atrial fibrillation, a heart rhythm disorder, and bleeding, which may be a concern for patients who are on medications aimed at preventing heart attacks or strokes.
Cardiovascular disease, including heart attacks and strokes, is the leading cause of death, killing 800,000 U.S. citizens annually. Cardiovascular drugs are also among the most prescribed medicines. According to data from IQVIA, atorvastatin — once sold by Pfizer (PFE) as Lipitor, but now generic — is among the most commonly prescribed medicines in the world, prescribed more than 108 million times in 2017. (A single patient can be prescribed a drug more than once during a year.)
Medicines to treat high triglycerides, as Vascepa does, are a smaller market. The most common one was prescribed 12 million times in 2017; Vascepa, at that point, was prescribed just 1 million times.
Vascepa is different from fish oil supplements that can be bought over-the-counter because it consists of just one of the fatty acids that have long been touted as having potential health benefits: eicosapentaenoic acid, or EPA. At one point, cardiologists often told patients to take fish oil pills, but many large studies have failed to show a consistent benefit. Amarin’s more purified pill was given at a higher dose, and it may be that the EPA in Vascepa has benefits that unpurified fish oil does not. One previous study of heart disease that did show a benefit, conducted in Japan, used only EPA.
At a meeting of outside experts held by the FDA in November, panelists unanimously backed the use of Vascepa in patients with established cardiovascular disease. Some were more uncertain about extrapolating from a single study in mostly high-risk patients to those at lower risk, apparently informing the FDA’s slightly more restrictive stance.
The FDA had been expected to approve Vascepa by a Dec. 28 regulatory deadline; the approval is one of several that have come earlier than expected this year.
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Amarin's fish-oil drug approved to prevent heart attacks and strokes - STAT
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