Bayer's Factor VIII drug gets FDA go-ahead
Germany's Bayer HealthCare has received an additional indication from the US Food and Drug Administration for its Kogenate FS antihemophilic factor (recombinant) as the only Factor VIII treatment for routine prophylaxis in pediatric patients.
The FDA approval of Kogenate to reduce the frequency of bleeding episodes and the risk of joint damage in patients aged 0-16 years with severe hemophilia A with no pre-existing joint damage is based on clinical data from a multicenter trial that included 65 boys with severe hemophilia A less than 30 months of age at study entry. Participants were followed for up to 5.5 years.
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