LFB S.A. ANNOUNCED TODAY THE ACCEPTANCE BY U.S. FOOD AND DRUG ADMINISTRATION OF THE FILED BIOLOGIC LICENSE APPLICATION FOR COAGULATION FACTOR VIIA RECOMBINANT, (EPTACOG BETA ACTIVATED)

LES ULIS, France, Jan 9 (Bernama-BUSINESS WIRE) -- LFB S.A., announced that its Biologic License Application (BLA), requesting marketing approval of Coagulation Factor VIIa (Recombinant) as a treatment for congenital hemophilia A or B in adolescent and adult congenital hemophilia A or B patients with inhibitors, has been accepted for review by the U.S. Food and Drug Administration (FDA). The BLA contains data from Phase 3 pivotal studies in the global PERSEPT (Program for the Evaluation of Recombinant Factor Seven Efficacy by Prospective Clinical Trials) program, designed to evaluate the safety and efficacy of Coagulation Factor VIIa (Recombinant).

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