FDA agrees to Amarin's off-label promotion of Vascepa

Irish biopharma company Amarin (Nasdaq: AMRN) says that settlement terms have been reached among the parties to resolve the Amarin First Amendment litigation (Amarin Pharma Inc et al v FDA et al, relating to off-label promotion of its prescription-grade omega-3 fatty acid Vascepa (icosapent).

Under the terms, the US Food and Drug Administration and the U.S. government have agreed to be bound by the a US district court judicial declaration last year that Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepacapsules (The Pharma Letter August 10, 2015). Amarin's expanded promotion of Vascepa, initiated following the August 2015 judicial declaration, continues as planned. Amarin’s shares rose 9% to $1.69 in after-hours trading on Tuesday. Vascepa, Amarin’s only marketed drug, generated sales of 81 million in 2015, a year-on-year rise of 51%.

As per the 2015 decision, Amarin was allowed to share information regarding the effects of Vascepa as demonstrated in the late-stage ANCHOR trial, testing the product in patients with persistently high triglycerides after statin therapy. The FDA-approved indication is as an adjunct to diet to lower triglyceride levels in adults with sever hypertriglyceridemia.