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BioMarin’s Roctavian & Argenx’s Efgartigimod Among Eight Hopefuls Awaiting EU Verdict

 
• By Vibha Sharma

Will BioMarin be second time lucky with its hemophilia gene therapy Roctavian in the EU? The European Medicines Agency could soon decide whether the product should be approved.

Red stamp and an imprint EMA (European Medicines Agency) on white surface. EMA is an agency of the EU in charge of the evaluation and supervision
Its decision time for drugs at the EMA’s CHMP meeting • Source: Alamy

The European Medicines Agency is this week due to decide whether to recommend pan-EU marketing approval for eight products, including BioMarin Pharmaceutical’s gene therapy, Roctavian (valoctocogene roxaparvovec), for severe hemophilia A, and argenx’s efgartigimod alfa for treating generalized myasthenia gravis.

Roctavian and efgartigimod alfa are among products that are listed as being up for an opinion on the

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