Policy & Regulation
US FDA approves Sevenfact for treatment of adults and adolescents with haemophilia A or B
2 April 2020 -

The United States Food and Drug Administration (FDA) has approved Sevenfact [coagulation factor VIIa (recombinant)-jncw] intended for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with haemophilia A or B with inhibitors (neutralising antibodies), it was reported on Wednesday.

The FDA granted approval of Sevenfact to Laboratoire Francais du Fractionnement et des Biotechnologies SA. Sevenfact contains an active ingredient expressed in genetically engineered rabbits. The active ingredient is a recombinant analogue of human FVII, which is expressed in the mammary gland of genetically engineered rabbits and secreted into the rabbits' milk. During purification and processing of the milk, FVII is converted into activated FVII (FVIIa). The recombinant DNA (rDNA) construct in the genetically engineered rabbits used for the production of Sevenfact was approved by the FDA's Center for Veterinary Medicine.

Dr Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said, 'Today's approval provides another treatment option for the control of bleeding episodes in adults and adolescents with haemophilia who have developed inhibitors. In addition to being an important option for patients, Sevenfact is the first product for haemophilia 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.'

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