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EU Fast-Track Success For BioMarin’s Valrox But Not For Amarin’s Vascepa

Filings For Both Products Are Due By Year End

 
• By Maureen Kenny

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.

Race_Track_Stopwatch
The EMA is to review BioMarin's planned marketing application more quickly • Source: Shutterstock

BioMarin’s potential new gene therapy for severe hemophilia A, Valrox (valoctocogene roxaparvovec), will be fast tracked through the system when the company files for pan-EU approval later this year.

The European Medicines Agency’s key scientific committee, the CHMP, granted BioMarin’s request for accelerated assessment of the company’s planned marketing...

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