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FDA approves Jivi for prophylactic treatment of hemophilia A
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The FDA approved antihemophilic factor (recombinant) PEGylated-aucl for the routine prophylactic treatment of hemophilia A among previously treated adults and adolescents aged 12 years or older.
The FDA also approved antihemophilic factor (recombinant) PEGylated-aucl (Jivi, Bayer) for on-demand treatment and perioperative management of bleeding for adults and adolescents with hemophilia A.
Jivi is a site-specific therapy that replaces factor VII, a protein needed to form blood clots, among patients with hemophilia A, with a half-life of 17.9 hours.
The initial recommended dosing regimen is 30 IU/kg to 40 IU/kg twice weekly, with the ability to dose every 5 days at 45 IU/kg to 60 IU/kg. Further dosing adjustments can be made based on bleeding episodes.
“As a physician who treats hemophilia A patients with a range of individualized needs, Jivi’s approved dosing allows me to adjust frequency based on their bleed episodes to maintain protection from bleeds, which is a serious concern among patients,” Mark Reding, MD, associate professor of medicine at University of Minnesota, said in a company-issued press release. “Jivi is a welcome option that addresses a growing patient need to integrate treatment with personal lifestyles.”
The FDA based this approval on results from the open-label phase 2/phase 3 PROTECT VIII trial. The analysis included 126 patients aged 12 or older with severe hemophilia A.
Results showed bleed protection and safety of up to a median of 1.9 years (range, 0-2.6).
“Today’s approval builds on our 25-year partnership with the hemophilia community and underscores our commitment to developing new therapies that help meet the needs of patients living with this life-long disease,” Carsten Brunn, president of Bayer Pharmaceuticals, Americas Region, said in the release. “Jivi’s proven efficacy with its unique dosing regimen is an important benefit to patients that we look forward to bringing to the global community, as we pursue additional regulatory approvals for Jivi in other regions around the world.”
Treatment with Jivi appeared well tolerated. The most common adverse reactions included headache, cough, nausea and fever. One previously treated adult developed a factor VIII inhibitor (1.7 BU/mL). However, repeat testing did not confirm the presence of a factor VIII inhibitor.