Vascepa Included In European Dyslipidemia Guidelines Ahead Of Approval
Amarin won't seek approval in the EU until later this year, but doctors there are encouraged to consider Vascepa for patients with high triglycerides despite statin therapy. Also, PCSK9 inhibitor guidelines were solidified for very high risk patients.
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Sales of the triglyceride-lowering medicine soared to $112.4m in the third quarter even before a label expansion that depends on the outcome of a vital US FDA advisory committee meeting on 14 November.
Amarin’s cardiovascular risk reducing drug, Vascepa, is among four new products being considered for accelerated assessment by the European Medicines Agency.
"We're planning for success," John Thero told Scrip in an interview, where he talked about the upcoming US advisory committee meeting for Vascepa, commercial expansion plans and deflected questions about a big pharma buyout.