When Vascepa, which is manufactured by Irish drugmaker Amarin, was first approved it was restricted to a fairly narrow patient group with very high levels of triglycerides in their blood. High triglycerides levels have been linked with a higher risk of heart disease.
Label expansion for Vascepa
The new recommendation, unanimously approved yesterday by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee, is for the drug to be used an adjunct to statin therapy in patients with elevated triglyceride levels as a means of reducing overall cardiovascular events.
As a result of its initially narrowed customer base, Amarin’s sales have been lower than hoped for. But based on the positive results of the drug maker’s REDUCE IT clinical trial and on the expected outcome yesterday’s recommendation, Amarin has boosted its full year sales outlook for the drug to $380 million to $420 million.
According to a report on the site Biopharmadive, company officials have said they expect future sales to be in the billions.
“Insurance companies have become so rigid about what drugs they will cover and for which populations, so the recommendation for label expansion is a game-changer for many. While the details on who will be covered by the decision have yet to be determined, yesterday's outcome brings Vascepa one step closer to reaching millions of Americans who remain at risk for cardiovascular events despite aggressive statin therapy,” said Harry Rice, PhD, vice president of regulatory and scientific affairs for the Global Organization for EPA and DHA Omega-3s (GOED).
Protecting the market
The differentiation between drug forms and supplement forms of omega-3s was long one of concentration. But as more and more ultra high concentrate forms of omega-3 dietary supplements come to market, that line is becoming blurred.
Amarin has vigorously sought to protect the market for its drug from dietary supplement companies it saw as treading on its turf. More than a year ago Amarin sued two dietary supplement manufacturers because it claimed they were using the results of the clinical drug trial to market their supplements.
In 2017 Amarin also made a Lanham Act complaint to the International Trade Commission, which was essentially an attempt to have ethyl ester forms of EPA classified as a drug, which, if successful, would have had grave implications for many supplements on the market. But earlier this year a federal court of appeals upheld the ITC’s decision not to hear the case.
Benefit to entire sector
Longtime omega-3s authority William Harris, PhD, of the Sanford School of Medicine at the University of South Dakota, said the panel’s recommendation could not be used in dietary supplement marketing per se, but any official recognition of the benefits of omega-3s is good news. In addition to his academic post, Harris is president and CEO in the omega-3s testing firm OmegaQuant.
“The rising tide floats more boats. This has got to ease the angst in the medical world that omega-3s don’t do anything,” he said.
“I’m sure this will be good for the omega-3s market in general even though there wouldn’t be any ability to use these direct outcomes to promote dietary supplements,” he added.
The panel’s recommendation adds to official recognition that omega-3s have health benefits, Harris said. Earlier this year, FDA approved a series of qualified health claims on omega-3s that marketers can use. The claims relate to the ability of omega-3s to lower blood pressure.