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Amarin sues FDA on free speech grounds

May 9, 2015 12:09 AM UTC

Amarin Corp. plc (NASDAQ:AMRN) filed a 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.

Amarin argued in its complaint 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). FDA issued a complete response letter for Vascepa in the indication last month; the >96% pure ethyl ester of eicosapentaenoic acid (ethyl-EPA) has been approved since 2012 to treat severe hypertriglyceridemia (≥500 mg/dL). ...