Amarin Seeks EU Fast-Track For Potential Cardiovascular Blockbuster
Three other companies have also requested an accelerated assessment
Executive Summary
Amarin’s cardiovascular risk reducing drug, Vascepa, is among four new products being considered for accelerated assessment by the European Medicines Agency.
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EU Accelerated Assessment Tracker
BioMarin has secured accelerated assessment at the European Medicines Agency for the planned filing of its potential new gene therapy for severe hemophilia A, Valrox. There was rejection for Amarin's Vascepa. The outcomes of more than a handful of other fast-track requests that companies have made for their planned or recent marketing authorization applications are still unknown.
EU Fast-Track Success For BioMarin’s Valrox But Not For Amarin’s Vascepa
Just one of four accelerated assessment requests that were decided on at the European Medicines Agency this month is known to have been granted – for BioMarin’s Valrox. There was rejection for Amarin; Roche and Orchard are keeping the outcomes to themselves.
Amarin CEO Thero On Gearing Up For Success Ahead Of The Big Vascepa Ad Comm
"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.