Amarin cardiovascular news
Amarin filed a lawsuit in the U.S. District Court for the Southern District of New York against FDA seeking a judicial declaration that the agency’s regulation prohibiting Amarin from providing “truthful and non-misleading information” to healthcare professionals about off-label use of Vascepa icosapent ethyl is an unconstitutional infringement of its First Amendment right to free speech, as well as its right to due process protected by the Fifth Amendment. In its complaint, Amarin argued that it should be allowed to inform doctors that Vascepa met all primary and secondary endpoints in the Phase III ANCHOR trial in combination with statins to treat patients with high triglyceride levels (200-499 mg/dL). Last month FDA issued a complete response letter concerning Amarin’s request to describe ANCHOR’s efficacy results with a disclaimer stating that the drug has not been demonstrated to reduce cardiovascular risk on Vascepa’s label. The more than 96% pure ethyl ester of eicosapentaenoic acid (ethyl-EPA) is marketed to treat severe hypertriglyceridemia, defined as triglyceride levels of greater than or equal to 500 mg/dL. ...