Bayer Jivi gets USFDA approval for pediatric patients 7 years of age and older with hemophilia A
The approval is based on data from the Alfa-PROTECT and PROTECT Kids studies.;
Whippany: Bayer announced that the U.S. Food and Drug Administration (FDA) has approved Jivi, a recombinant DNA-derived, extended half-life factor VIII concentrate, for use in pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency).
JIVI is a recombinant DNA-derived, Factor VIII concentrate that was first approved by the FDA in August 2018 for previously treated adults 12 years of age and older with hemophilia A for:
- On-demand treatment and control of bleeding episodes
- Perioperative management of bleeding
- Routine prophylaxis to reduce the frequency of bleeding episodes.
With this new FDA approval, Jivi can now also be used in previously treated adults and pediatric patients 7 years and older with hemophilia A (congenital Factor VIII deficiency) for the same indications.
The approval is based on data from the Alfa-PROTECT and PROTECT Kids studies, demonstrating Jivi’s safety and efficacy in children aged 7 to under 12 years with severe hemophilia A.
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