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Amarin wins case against FDA to promote Vascepa for off-label uses

Published on 10/03/16 at 12:19pm

Amarin has announced a settlement with the US Food and Drug Administration (FDA) that resolves the dispute over the Irish-based company’s right to promote off-label use of Vascepa (icosapent ethyl).

Amarin invoked the First Amendment of the Constitution in its legal battle, and the FDA has chosen to accept the original judicial decision made on August 7 2015, that allows Amarin to engage in truthful and non-misleading speech to promote the off-label use of the drug, which the US drugs regulator approved as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.

The company now intends to expand its promotion of Vascepa as originally planned.

John Thero, president and chief executive at Amarin, comments: “We are pleased to announce this amicable resolution with and among the physician plaintiffs, FDA and the US government and look forward to continuing to promote Vascepa in a truthful, non-misleading and responsible manner.

“With more truthful and non-misleading information readily available to healthcare professionals about the potential of Vascepa to improve cardiovascular health, this settlement serves the public interest by supporting informed medical decisions for tens of millions with persistent high triglycerides.”

In the judicial decision, it is indicated that that “the combination of statements and disclosures that Amarin proposes to make to doctors relating to the use of Vascepa to treat persons with persistently high trigylcerides… is truthful and not misleading.” Furthermore, a disagreement resolution provision has been set up to prevent further litigation and avoid any future dispute and that the court’s decision in no way limits Amarin’s right to free speech under the First Amendment.

Amarin has indicated that it will continue to research the potential of Vascepa and publish results on an ongoing basis. Currently, the REDUCE-IT clinical trial is testing whether Vascepa, when added to statin therapy, will significantly reduce cardiovascular risk compared to statins alone in high risk patients with elevated triglyceride levels.

Sean Murray

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