The US Food and Drug Administration (FDA) has expanded approval for Bayer HealthCare’s Kogenate® FS, a recombinant factor FVIII therapy (rFVIII), to include routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A. Kogenate® FS is already approved for the control and prevention of bleeding episodes and peri-operative management in adults and children with hemophilia A. It is also approved for routine prophylaxis to reduce the frequency of bleeding episodes and prevent joint damage in children with severe hemophilia A.
The approval is based on data from the SPINART study, in which 84 patients with severe hemophilia (FVIII <1%) ages 15 to 50 were randomized to receive either prophylaxis (three infusions per week) or on-demand therapy, as needed to treat bleeds.
Patients who received prophylaxis experienced significantly fewer bleeds compared to patients treated on-demand regardless of baseline subgroups examined including age, bleeding history, and presence or absence of target joints. Patients in the on-demand group had on average 15.2 times as many bleeds as those in the prophylaxis group. The mean annualized bleed rates were 37 in the on-demand group versus 2 in the prophylaxis group. The median annualized bleed rate in the on-demand group was 33 versus 0 in the prophylaxis group. In the prophylaxis group, 22 of 42 (52%) people experienced no bleeding, and 12 of 42 (29%) had one or two bleeds during the follow-up period.
“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, MD, 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.”
Source: Market Watch, May 12, 2014
