Adding another commercial product to its hemophilia portfolio, Bayer has received FDA approval for its long-acting recombinant Factor VIII replacement therapy for hemophilia A — giving it a green light for a field that Roche has begun to dominate with Hemlibra.
The frequency of treatment is key here, Bayer says. Being approved for a step-wise prophylaxis dosing regimen means that patients will start out with twice-weekly infusions but can move on to dose every five days, or even more.
Previous Phase III results indicated that the treatment, Jivi, offered protection to previously treated patients from bleeds even when administered once every seven days.
Bayer has been looking to rival key players in the hemophilia A market, which has been dominated by Shire and now Sanofi, through its acquisition of Bioverativ. Roche, though, has been making steady gains with Hemlibra, which will likely soon gain an OK for expanded use among 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,” said Mark Reding, lead investigator of the study and medicine faculty at the University of Minnesota. “Jivi is a welcome option that addresses a growing patient need to integrate treatment with personal lifestyles.”
The FDA label also covers the use of of Jivi in on-demand treatment and in surgery settings, also among previously treatment patients aged 12 or older.
Bayer has bagged the approval just a month before Roche is set to find out whether its blockbuster drug Hemlibra can also be used to treat hemophilia A patients who haven’t developed factor VIII inhibitors.
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