Amarin Says REDUCE-IT Results Are Off Limits To Omega-3 Supplement Claims
This article was originally published in The Pink Sheet
REDUCE-IT results are limited to Amarin's Vascepa "and cannot be extrapolated to omega-3 products that are materially different based on, for example, composition, dosage, and regulatory status," pharma firm says in complaints against Coromega and Omax. Amarin seeks to stifle the omega-3 supplement firms despite First Amendment argument it made in successful litigation against FDA to make truthful statements about its products even though the information is not approved by the agency.
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National Advertising Division, in rare review of an Rx drug firm’s challenge of supplement ad claims, reported Innovix Pharma pulled health claims for OmegaVia brand supplements challenged by Amarin. Innovix prevailed in defending its labeling as accurate and its name as not false advertising.
Coromega Health and Omax will issue press releases explaining that the Amarin study each firm noted in previous releases was not relevant to omega-3 supplements. Releases subject to publication within three days of each settlement's finalization include six mentions of Amarin's Rx prescription triglyceride-lowering fish oil, Vascepa.
Cardiovascular outcomes data exceeded expectations for the fish oil pill, vindicating Amarin, which has fought long and hard for Vascepa's place in the CV disease prevention market. A filing based on REDUCE-IT is expected in early 2019.