By Fineline Cube 
German pharmaceutical giant Bayer AG (ETR: BAYN) announced this week that it has received an indication extension approval from the US Food and Drug Administration (FDA) for its Jivi, a recombinant DNA-derived, extended half-life factor VIII concentrate. The approval expands Jivi’s use to include the treatment of pediatric patients aged 7 years and older with hemophilia A (congenital Factor VIII deficiency).
Clinical Trial Basis
The FDA’s decision was based on positive results from the Alfa-PROTECT and PROTECT Kids trials. These trials demonstrated Jivi’s favorable safety and efficacy profile in children aged 7 to 12 with severe hemophilia A.
Previous Approval
Jivi initially received FDA approval in August 2018 for on-demand treatment and bleeding episode control, perioperative bleeding management, and routine prophylaxis (to reduce bleeding frequency) in previously treated patients aged 12 years and older with hemophilia A.-Fineline Info & Tech