-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).

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. This significant milestone reflects Bayer’s ongoing commitment to providing effective treatment options for the hemophilia community.

Jivi was first granted approval by the FDA in August 2018 for use in 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.

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.

"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.”

Bayer continues to prioritize support for the hemophilia community, and we are excited to offer Jivi as a treatment option for patients and their families.