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EU Accelerated Assessment Tracker

Executive Summary

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.

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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.

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