BioMarin resubmits Marketing Authorization Application to European Medicines Agency for valoctocogene roxaparvovec to treat severe haemophilia A
Submission for this investigational gene therapy includes data from 134 subjects in phase 3 GENEr8-1 study (minimum 1 year follow up), as well as 4 and 3 years of follow-up from 6e13 vg/kg and 4e13 vg/kg dose cohorts, respectively, in ongoing phase 1/2 dose escalation study.
Source:
Biospace Inc.