Posted by Michael Wonder on 24 Dec 2019
European Medicines Agency validates BioMarin's marketing authorisation application for valoctocogene roxaparvovec to treat severe haemophilia A
23 December 2019 - Potential first gene therapy in Europe directed at any type of haemophilia.
BioMarin announced today that the European Medicines Agency validated the Company's marketing authorisation application for its investigational gene therapy, valoctocogene roxaparvovec, for adults with severe haemophilia A.
The MAA review will commence in January 2020 under accelerated assessment.
