Decision: Favourable
Study Title:
A Phase 3 open-label, multicenter study of the long-term safety and efficacy of intravenous recombinant coagulation factor VIII Fc-von willebrand factor-XTEN fusion protein (rFVIIIFc-VWF-XTEN; BIVV001) in previously treated patients with severe hemophilia A
NREC Code:
22-NREC-CT-084
Decision:
Favourable
Meeting Date:
27/04/2022
Study Type:
CT application
Principal Investigator:
Prof. Beatrice Nolan
PI Institution:
CHI Crumlin
Sponsor:
Sanofi