FDA Approves Jivi for Pediatric Patients Aged 7 to 12 Years With Hemophilia A


Treatment options for children with hemophilia A have expanded with the FDA approval of Bayer’s Jivi antihemophilic factor (recombinant), PEGylated-aucl for the treatment of pediatric patients between 7 and 12 years of age.1

Hemophilia diagnosis is typically confirmed through specialized blood testing shortly after birth, and in some cases, prenatal genetic testing can detect hemophilia before delivery. | Image credit: Denira – stock.adobe.com

Previously, Jivi was approved in September 2018 for adults and adolescents aged 12 years and older with this hemophilia subtype.2

According to data collected from federally funded hemophilia treatment centers between 2012 and 2018, an estimated 33,000 males in the US are living with the disorder.3

Hemophilia A, which results from low levels of clotting factor 8, is 3 to 4 times more common than hemophilia B, which is caused by low levels of clotting factor 9.4 Most individuals with hemophilia in the US are diagnosed at an early age. CDC data show that the median age at diagnosis is:

  • 1 month for severe hemophilia
  • 8 months for moderate hemophilia
  • 36 months for mild hemophilia

The CDC also reports that approximately two-thirds of infants diagnosed with hemophilia have a known family history of the condition. Diagnosis is typically confirmed through specialized blood testing shortly after birth, and in some cases, prenatal genetic testing can detect hemophilia before delivery.

For the one-third of infants born with hemophilia in families without a known history, diagnosis often occurs following an unusual bleeding episode.

References

1. U.S. FDA grants approval for Jivi® antihemophilic factor (recombinant), PEGylated-aucl in pediatric patients 7 to under 12 years of age with hemophilia A (congenital factor VIII deficiency). Press release. Bayer; May 19, 2025. Accessed May 19, 2025. https://www.businesswire.com/news/home/20250519742201/en/U.S.-FDA-Grants-Approval-for-Jivi-Antihemophilic-Factor-Recombinant-PEGylated-aucl-in-Pediatric-Patients-7-to-Under-12-Years-of-Age-With-Hemophilia-A-Congenital-Factor-VIII-Deficiency

2. Joszt L. FDA approves new drug for adults and adolescents with hemophilia A. September 2, 2018. Accessed May 19, 2025. https://www.ajmc.com/view/fda-approves-new-drug-for-adults-and-adolescents-with-hemophilia-a

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