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First Gene Therapy for Adults with Severe Hemophilia A, BioMarin's ROCTAVIAN™ (valoctocogene roxaparvovec), Approved by European Commission (EC)

Summary by Ground News
Roctavian (valoctocogene roxaparvovec) granted conditional marketing authorization (CMA) for the treatment of severe hemophilia A (congenital Factor VIII deficiency) in adult patients without a history of Factor VIII inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (AAV5) Maintains Orphan Drug Designation (ODD) in the EU Providing 10-years of market exclusivity.
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