Bayer recently announced that the company’s hemophilia A therapy Jivi® has been granted an expanded indication from the U.S. Food and Drug Administration (FDA). Jivi is a long-acting site-specifically PEGylated recombinant factor VIII therapy that was first FDA-approved in 2018 for use in previously treated individuals with hemophilia A, including adolescents and adults 12 years of age and over. This indication encompassed prophylactic, on-demand, and perioperative management of bleeding.
The expanded indication now includes children with hemophilia A who are seven years of age and older. According to a new Bayer press release, the approval is based on data from the Alfa-PROTECT and PROTECT Kids clinical 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.”
Read the full prescribing information.
Source: Bayer press release dated May 19, 2025
