Update Regarding the FDA Submission for Coagulation Factor VIIa (Recombinant), activated eptacog beta*
On January 9, 2017, HEMA Biologics, LLC announced Food and Drug Administration (FDA) acceptance of the Biologics License Application (BLA), for what could become their first commercial treatment for rare bleeding disorders in the United States. Since that time, HEMA Biologics and LFB, S.A., (holder of the BLA and partner) have been working with the agency to address questions raised during the application review process.
HEMA Biologics is pleased to share that so far FDA has no efficacy or safety concerns arising from the Phase 3 clinical trial evaluating Coagulation Factor VIIa (Recombinant)* in the treatment of bleeding in adults and adolescents with hemophilia who have inhibitors.
HEMA Biologics will continue to actively engage and partner with the bleeding disorders community while the issues are addressed.
Please note that eptacog beta remains an investigational drug and has not received approval from the FDA. The information in this announcement is not intended to draw any conclusions regarding the efficacy or safety of eptacog beta for any indication.
*Coagulation Factor VIIa, (Recombinant) is a variant of human Factor VIIa which is also known by its INN designation as eptacog(um) beta, recombinant.