Supreme Court Doesn't Bite On Amarin Appeal In Omega-3 Fair Trade Complaint
The court included its decision on Amarin’s ’s petition for a writ of certiorari among the single-line denials of nearly 200 appeals to consider decisions in civil litigation and convictions in criminal cases. However, Amarin still eyes curbing competition from omega-3 supplements.
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US Wellness Market In 2019: Amarin Wins, Loses On Supplements; Gottlieb Leaves With Consumer Health Flourish
In Amarin’s “education process” about indication as an add-on to statin therapy to help cut CV risk in high-risk patients, it “will also be emphasizing how Vascepa is different from” Rx drugs fenofibrate and niacin “and omega-3 mixtures,” says CEO John Thero.
Focus of negotiations with agency will be on breadth of population encompassed by a cardiovascular risk reduction indication; most advisory committee members favored a broad claim for secondary and primary prevention reflecting the REDUCE-IT trial population, but some strongly opposed an indication that includes patients without established CV disease.