US district court rules favorably for Amarin over off-label Vascepa promotion

Biopharma company Amarin (Nasdaq: AMRN) has received a favorable US district court ruling regarding its ongoing lawsuit against the US Food and Drug Administration over the off-label promotion of Vascepa (icosapent).

Amarin’s shares climbed as much as 15% on the news that the court said, in the preliminary order, that Amarin is allowed to “engage in truthful and non-misleading speech to promote” Vascepa, a prescription-grade omega-3 fatty acid, to health care professionals. This is for certain uses not covered by the current FDA-approved indication of sever hypertriglyceridemia.

Amarin is now 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. Amarin can also promote the product using peer-reviewed journals that present the “current state of scientific research related to the potential of Vascepa to reduce the risk of cardiovascular disease.”