Amarin on Tuesday announced that it entered into an agreement with the FDA allowing the drugmaker to promote Vascepa (icosapent ethyl) for off-label uses. Specifically, the FDA agreed to be bound by a US district court ruling permitting Amarin to engage in "truthful and non-misleading speech" promoting the off-label uses of Vascepa. Amarin CEO John Thero stated "this settlement serves the public interest by supporting informed medical decisions for tens of millions of patients with persistent high triglycerides."
The FDA approved Vascepa as an adjunct to diet to lower triglyceride levels in adults with severe hypertriglyceridaemia in 2012. Last May, Amarin filed a lawsuit against the FDA alleging that the agency's restrictions limiting off-label promotion violated constitutional rights protecting free speech. The drugmaker said it wanted to be able to share certain information with healthcare professionals, including efficacy data from the Phase III ANCHOR trial of Vascepa in patients with high triglyceride levels despite statin therapy, as well as peer-reviewed scientific publications relevant to the potential effect of EPA omega-3 fatty acids on reducing the risk of coronary heart disease.
Amarin and the FDA jointly requested a continued stay in court proceedings last month to continue negotiations towards a settlement.
For related analysis, see ViewPoints: Amarin, FDA settlement confirms 'truthful and non-misleading' is new normal for drug promotion and ViewPoints: Another domino falls in industry's fight against FDA's off-label promotion rules.
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