FDA Review Underway for Eptacog Beta in Hemophilia
LFB S.A. announced that the Food and Drug Administration (FDA) has accepted for review the Biologic License Application (BLA) of its recombinant Coagulation Factor VIIa (eptacog beta, activated) for the potential treatment of congenital hemophilia A or B in adolescents and adults with inhibitors.
The BLA submission was supported by data from PERSEPT (Program for the Evaluation of Recombinant Factor Seven Efficacy by Prospective Clinical Trials), a global, Phase 3 clinical trial program which evaluated the efficacy and safety of Coagulation Factor VIIa (recombinant) in congenital hemophilia A or B patients with inhibitors.
Eptacog beta, a novel recombinant form of human Factor VIIa, is under development utilizing LFB SA's proprietary rPRO technology.
For more information visit Groupe-lfb.com.