FDA broadens approval for fish-oil derived heart disease drug
The US Food and Drug Administration has expanded its approval of a fish oil-derived drug designed to reduce the risk of cardiovascular events in adults with elevated triglyceride levels. The drug was initially approved in 2012, but limited to a highly specific sub-section of patients. This new approval broadens the drug’s potential administration to include millions more patients as an adjunctive treatment to regular statin therapy.
A variety of studies in recent years have reported mixed results for omega-3 fish oil supplements in effectively reducing the risk of cardiovascular disease and stroke. A massive metastudy in 2018 found no evidence that omega-3 supplementation conferred protective benefits against coronary heart disease, or reduced all-cause mortality.
Vascepa was initially approved by the FDA in 2012 to treat patients with severe triglyceride levels. The drug essentially takes one particular fatty acid found in fish oil, called eicosapentaenoic acid (EPA), and delivers it in a purified concentrated form. The highly limited nature of Vascepa’s approval resulted in several years of conflict between the FDA and the drug’s developer Amarin.
Amarin unsurprisingly wanted to broaden its market for the drug to the millions of Americans suffering from more general cardiovascular issues. This subsequently resulted in years of court battles between Amarin and the FDA, hinging on the question of how broadly a pharma company could market an approved drug for off-label uses. Amarin was ultimately somewhat successful in arguing it had a free speech right to market a drug for off-label uses as long as any claims it made were “truthful”.
The long game, however, was to get official FDA approval for broader clinical uses of Vascepa. This latest FDA approval certainly offers the company the broader approval it has been long seeking, although there are still some distinct limitations.
The new approval for Vascepa is only as an add-on therapy for patients already on statins, and with triglyceride blood levels higher than 150 milligrams per deciliter. The approval is based on a study published in the New England Journal of Medicine in early 2019. The placebo-controlled trial enrolled over 8000 subjects followed for an average of five years. Half of the cohort received a placebo, while the other half took 4 grams of Vascepa a day.
The reported results found the Vascepa cohort displayed 25 percent less adverse cardiovascular events compared to the placebo group. Following a unanimous vote from an independent advisory panel in November, the FDA has now officially expanded its approval of Vascepa.
“The FDA recognizes there is a need for additional medical treatments for cardiovascular disease,” says John Sharretts, acting deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “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.”
Why there seems to be so much discordance in clinical trial results exploring the effect of fish oils on cardiovascular health is still a major question. Some experts suggest the variations can be explained by purity of certain compounds and concentrations in dosage. Cecilia Low Wang, a member of the FDA advisory panel recommending Vascepa’s approval, points out the oversight in pharmaceutical drug production, compared to unregulated dietary supplements, may underpin why so many different fish oil clinical trials report conflicting results.
"Pharmaceutical drugs are regulated by the FDA, so the manufacturing has to meet high standards, so you can be sure that when you take it you are getting the amount listed on the label, and it is safe and free of impurities," Low Wang said to NPR in November. "Dietary supplements are not held to the same standard and are not required to demonstrate this level of quality, safety or effectiveness before being marketed.”