Bayer gets green light to sell long-acting hemophilia A therapy as Roche muscles in with Hemlibra
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.
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