Posted by Michael Wonder on 25 May 2021
European Medicines Agency grants BioMarin's request for accelerated assessment of valoctocogene roxaparvovec for treatment of severe haemophilia A
24 May 2021 - MAA resubmission on track for June 2021.
BioMarin announced today that the EMA has granted its request for accelerated assessment of valoctocogene roxaparvovec, for adults with severe haemophilia A.
The submission will include 52 weeks of data from the Phase 3 GENEr8-1 study, as well as four and three years of follow-up from the respective dose cohorts in the ongoing Phase 1/2 dose escalation study.
