FDA approves Bayer's Kogenate FS Antihemophilic Factor VIII (recombinant)
The FDA has approved a new indication for Bayer's Kogenate FS antihemophilic factor VIII (recombinant) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A. The approval is based on data from the SPINART study, in which 84 patients ages 15 to 50 were randomized to either prophylaxis (25IU/kg three times per week) or on-demand treatment.
"In Bayer's SPINART study, adult patients with hemophilia A on the prophylactic regimen experienced significantly fewer bleeding events than those using on-demand treatment," said Marilyn Manco-Johnson, M.D., Principal Investigator of the study and director, Mountain States Regional Hemophilia and Thrombosis Center, University of Colorado at Denver and Health Sciences Center. "Such clinical information can help healthcare professionals provide appropriate treatment advice to their patients."
In the study, patients were stratified based on target joints (presence/absence) and the number of bleeding events in the previous six months (>=15 v.
The most common adverse reactions (>=4%) observed in clinical trials were inhibitor formation in previously untreated and minimally treated patients, skin-related hypersensitivity reactions (e.g., rash, pruritus), infusion site reactions (e.g., inflammation, pain) and central venous access device (CVAD) associated infections.
Patients who received prophylaxis experienced significantly fewer bleeds (p