Valoctocogene roxaparvovec granted accelerated assessment for treatment of severe Haemophilia A by European Medicines Agency (EMA)

Company plans to submit a Marketing Authorisation Application in June 2021 for this gene therapy which stimulates the production of factor VIII, a blood coagulation factor. The submission will include 52 weeks data from the Phase 3 GENEr8-1 study.

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Biospace Inc.