FDA Approves Bayer’s Jivi Antihemophilic Factor

FDA has approved Bayer’s Jivi, a recombinant DNA-derived, extended half-life factor VIII concentrate, for use in pediatric patients aged seven to 12 with hemophilia A (congenital factor VIII deficiency). A company statement says the approval was based on data from the Alfa-PROTECT and PROTECT Kids studies that demonstrated Jivi’s safety and efficacy in children aged seven to 12 years with severe hemophilia A.

Jivi was approved by FDA in 8/2018 for use in previously treated adults aged 12 and older with hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.

The treatment is not indicated for children less than seven years of age due to a greater risk for hypersensitivity reactions and/or loss of efficacy, in previously untreated patients, and for treatment of von Willebrand disease.