Investing.com -- Bayer AG (XETRA:ETR:BAYGN)(OTC:BAYRY) has received approval from the U.S. Food and Drug Administration (FDA) for its product Jivi, a recombinant DNA-derived, extended half-life factor VIII concentrate. The approval allows for the use of Jivi in treating pediatric patients aged 7 and older who are diagnosed with hemophilia A, also known as congenital Factor VIII deficiency.
The FDA’s approval is grounded on data from the Alfa-PROTECT and PROTECT Kids studies. These studies showcased Jivi’s safety and effectiveness in treating children aged between 7 and under 12 years who have severe hemophilia A. This approval marks a significant step in Bayer’s continuous effort to provide effective treatment options for those suffering from hemophilia.
Jivi first received FDA approval in August 2018. The approval was for use in previously treated adults aged 12 and older who have hemophilia A. The uses included on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.
However, Jivi is not approved for use in children under the age of 7 due to the increased risk of hypersensitivity reactions and/or loss of efficacy. It is also not indicated for previously untreated patients, or for the treatment of von Willebrand disease.
Jessica Charlet, Scientific Director at Bayer, expressed the company’s dedication to the hemophilia A community. She stated that the FDA’s approval for pediatric patients aged 7 to under 12 years is a reflection of Bayer’s commitment to the hemophilia A community. It also underscores the company’s dedication to supporting families throughout their treatment journey.
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