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Group petitions FDA to overturn rescission of ANCHOR SPA

December 14, 2013 1:29 AM UTC

A group comprised mostly of Amarin investors sent a Citizen's Petition to FDA asking FDA Commissioner Margaret Hamburg to overturn the agency's October decision to rescind an SPA for the Phase III ANCHOR trial of Vascepa icosapent ethyl from Amarin Corp. plc (NASDAQ:AMRN). The biotech is seeking to expand Vascepa's label based on data from ANCHOR to include treatment of high triglycerides, defined as triglyceride levels 200 mg/dL or greater and less than 500 mg/dL, in patients with mixed dyslipidemia. The sNDA has a Dec. 20 PDUFA date (see BioCentury Extra, Oct. 29).

In its petition, the group --- which calls itself the EPA Drug Initiative -- asked Hamburg to conduct an independent scientific review of the three cardiovascular outcome trials that FDA's reviewing division cited when rescinding the SPA for ANCHOR. The petition also requested Hamburg investigate the division for possible misconduct and delay the PDUFA date for Vascepa's sNDA. FDA said it is reviewing the petition and will respond directly to the initiative. ...