PHARMA/BIOTECH Update: Kogenate FS Approved for Routine Prophylaxis
May 12, 2014; posted by: WeBleed staff
Bayer HealthCare announced this morning that the U.S. Food and Drug Administration (FDA) has approved Bayer’s Kogenate FS antihemophilic factor VIII (recombinant) therapy for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.
The approval is based on Bayer’s SPINART study of 84 patients between the ages of 15 and 50 that were randomized to either a prophylactic or on-demand treatment regiment.
“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 the Director, Mountain States Regional Hemophilia and Thrombosis Center at the University of Colorado. “Such clinical information can help healthcare professionals provide appropriate treatment advice to their patients.”
Please click here to read the entire release.
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Image credit: Bayer Pharmaceuticals
