FDA Approves New Recombinant Factor VIIa Therapy
The U.S. Food and Drug Administration (FDA) recently approved Sevenfact, a new recombinant factor VIIa therapy manufactured by the French biotechnology company Laboratoire Francais du Fractionnement et des Biotechnologies (LFB). The FDA approval is for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors. Sevenfact is unique in that its active ingredient, a recombinant analog of the human FVII protein, is expressed in the mammary gland of genetically engineered rabbits.
“Today’s approval provides another treatment option for the control of bleeding episodes in adults and adolescents with hemophilia who have developed inhibitors,” said Dr. Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “In addition to being an important option for patients, Sevenfact is the first product for hemophilia treatment that contains an active ingredient obtained from rabbits genetically engineered to produce a protein necessary for blood coagulation. This approval is an example of our efforts to advance safe biotechnology innovations to support patient health.”
Hema Biologics, a Kentucky-based biopharmaceutical company, will be responsible for the commercialization and distribution of Sevenfact in the U.S. and Canada.
“Patients and families impacted by inhibitors have limited options available for the treatment and control of bleeding. As inhibitor patients continue to suffer the consequences of bleeding, bypassing agents will remain an essential part of disease management,” explains Dr. Allan Alexander, Vice President of Medical Affairs at HEMA Biologics. “We are pleased to bring SEVENFACT, a treatment that provides a proven hemostatic benefit in the setting of inhibitor-related bleeding along with demonstrated bleed resolution using a single dose.”
Source: FDA news release dated April 1, 2020