FDA will Review LFB's Application for Recombinant Factor VIIa Therapy
Multinational biopharmaceutical company LFB S.A. recently announced that the US Food and Drug Administration (FDA) has accepted for review the Biologic License Application (BLA) of the company’s recombinant factor VIIa product. A BLA is a request to the FDA for permission to introduce, or deliver for introduction, a biologic product into interstate commerce. The product, known as Eptacog Beta, was developed for the treatment of congenital hemophilia A or B and inhibitors in adolescents and adults.
Included in the BLA are data from phase 3 studies as part of PERSEPT (Program for the Evaluation of Recombinant Factor Seven Efficacy by Prospective Clinical Trials). The purpose of the global study is to evaluate the safety and efficacy of Eptacog Beta.
Eptacog Beta was developed using LFB S.A.’s proprietary rPRO™ technology, which uses recombinant genetic material that is coded to produce a specific therapeutic protein, in this case activated factor VII (FVIIa). The genetic codes are then inserted into a mammalian embryo, which leads to the production of the desired proteins through the milk of the lactating mammal. Eptacog Beta is manufactured by Framingham, Massachusetts-based LFB USA, a subsidiary of LFB S.A.
“This represents a major step toward LFB’s goal of making an innovative recombinant Factor VIIa treatment available for the treatment of hemophilia A and B patients with inhibitors to Factor VIII or IX,” said Christian Béchon, Chairman and Chief Executive Officer, LFB S.A.
Source: LFB SA news release dated January 6, 2017