Bayer Jivi gets USFDA approval for pediatric patients 7 years of age and older with hemophilia A

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.

"Bayer remains dedicated to meeting the needs of the hemophilia A community," stated Jessica Charlet, Scientific Director. “The FDA’s approval for pediatric patients 7 to <12 years of age is reflective of Bayer’s commitment to the hemophilia A community and underscores our commitment to supporting families through their treatment journey.”

According to Bayer, Jivi’s initial recommended dosing for children 7 to under 12 years of age is 60 IU/kg twice weekly. Adjust the dose based on the patient’s clinical response and/or recovery. The recommended initial dosage regimen for adults and adolescents is (30-40 IU/kg) twice weekly with the ability to dose every five days (45-60 IU/kg) and further individually adjust to less or more frequent dosing based on bleeding episodes. Jivi is also approved for on-demand treatment and the perioperative management of bleeding in the same population.

JIVI is not indicated for use in:

• • Children <7 years of age due to a greater risk for hypersensitivity reactions and/or loss of efficacy.
  • Previously untreated patients (PUPs).
  • Treatment of von Willebrand disease.