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Officials with the FDA have approved Bayerâ€™s antihemophilic factor [recombinant] PEGylated-aucl, BAY94-9027 (Jivi), for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older.
Officials with the FDA have approved Bayer’s antihemophilic factor [recombinant] PEGylated-aucl, BAY94-9027 (Jivi), for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older, according to the company.
BAY94-9027 is a recombinant factor VIII replacement therapy with a half-life of 17.9 hours. The initial recommended regimen is twice weekly (30-40 IU/kg), but dosing can be adjusted every 5 days (45-60 IU/kg) and can be further adjusted individually to less or more frequency based on bleeding episodes, according to Bayer.
The drug is also approved for on-demand treatment and the perioperative management of bleeding in the same population.
This approval is based on data from the 36-week phase 2/3 PROTECT VIII clinical trial, which included 126 previously treated patients 12 years or older with severe hemophilia A. Treatment with BAY94-9027 demonstrated bleed protection and safety of up to a median of 1.9 years. The drug was well tolerated in the majority of adult and adolescent patients.
“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,” lead trial investigator Mark Reding, MD, associate professor of medicine at the University of Minnesota, said in a prepared statement.
The most commonly reported adverse effects in the trial were headache, cough, nausea, and fever. A FVIII inhibitor (1.7 BU/mL) was reported in one previously treated adult subject. Repeat testing did not confirm the presence of a FVIII inhibitor.
BAY94-9027 is Bayer’s third FDA-approved hemophilia A treatment, according to the press release.
Bayer Receives FDA for Jivi, New Hemophilia A Treatment With Step-Wise Prophylaxis Dosing Regimen [news release]. Bayer’s website. https://www.bayer.us/en/newsroom/press-releases/article/?id=123236. Accessed August 30, 2018.