The U.S. Food and Drug Administration (FDA) has approved BAY94-9027 for the treatment of adults and adolescents (≥12 years) with previously treated hemophilia A.
The recombinant factor VIII replacement therapy was approved based on results from the phase II/III PROTECT VIII trial of previously treated adults and adolescents, which demonstrated bleed protection and safety of up to a median of 1.9 years (range = 0-2.6 years).
BAY94-9027 is indicated for prophylactic, on-demand, and perioperative management of hemophilia A. The most frequently reported adverse events were headache, cough, nausea, and fever.
Source: Bayer press release, August 30, 2018.