Advisory committee planned for Vascepa sNDA

Amarin Corp. plc (NASDAQ:AMRN) said FDA notified the company that an advisory committee will meet on Oct. 16 to discuss an sNDA for hypertriglyceridemia drug Vascepa icosapent ethyl. The company is seeking to expand the drug's label to include treatment of adult patients with high triglycerides -- defined as triglyceride levels greater than or equal to 200 mg/dL and less than 500 mg/dL -- with mixed dyslipidemia. The PDUFA date for the sNDA is Dec. 20. ...