Pharmaceuticals company Bayer HealthCare announced on Monday that the US Food and Drug Administration (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.
Additionally, the safety objectives were met and adverse events were consistent with the existing safety profile for Kogenate FS.
Bayer has since refined its program, enabling hemophiliac treatment centers and hospitals and home healthcare companies to purchase Kogenate FS
from Bayer without requiring patients to be enrolled.
is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no pre-existing joint damage.
In addition to Oncology products, BHC's Specialty Pharmaceuticals business' portfolio will comprise Kogenate FS
for the treatment of haemophilia, and Trasylol, which is used during open-heart surgery.
The Program gives individuals with hemophilia A in the United States a one-time opportunity to experience treatment with Kogenate FS
(Antihemophilic Factor (Recombinant), Formulated with Sucrose) with BIO-SET, a needleless reconstitution system, as well as the accompanying support programs and services available through Bayer.
Furthermore, Bayer Corporation has not released Kogenate FS
onto the U.