Amarin endocrine/metabolic news

The U.S. District Court for the Southern District of New York granted preliminary relief to allowing Amarin to engage in “truthful and non-misleading speech free from the threat” of prosecution for misbranding under the First Amendment to promote off-label use of Vascepa icosapent ethyl. The greater than 96% pure ethyl ester of eicosapentaenoic acid (ethyl-EPA) is approved in the U.S. as an adjunct to diet to reduce triglyceride levels in adults with triglyceride levels above 500 mg/dL. Amarin filed the suit weeks after FDA issued a complete response letter denying Amarin’s request to include language on Vascepa’s label, with certain disclaimers, describing clinical efficacy data of the drug in adults with baseline triglyceride levels between 200 and 499 mg/dL. Thus, use of Vascepa in patients with triglycerides of 200-499 mg/dL is considered off-label.

According to Amarin’s suit, FDA’s interpretation of off-label promotion by a drug manufacturer as misbranding put Amarin at risk for criminal prosecution. The suit is also seeking a declaration that FDA’s regulations are an unconstitutional infringement on its right to free speech and due process, and preliminary and permanent injunctions preventing FDA from taking action against Amarin on the basis of truthful, non-misleading speech used in off-label promotion of Vascepa. During oral arguments held in July, Amarin said that as an alternative to an injunction, effective relief could constitute a declaration that its intended communications are protected against a misbranding action. ...