FDA nod to Bayer’s Kogenate(R) FS for routine prophylaxis in hemophiliac children
The U.S. Food and Drug Administration has approved Bayer HealthCare’s Kogenate(R) FS for routine prophylaxis in children suffering from hemophilia. The drug will be used to reduce the incidence of joint damage and lower the frequency of bleeding episodes in patients below the age of 16 years. The approval makes Kogenate(R) FS the only factor VIII treatment regarded as safe and effective for routine prophylaxis by the FDA.The study on which the approval is based had special emphasis on index joints like elbow, knee and ankle that are most prone to bleeding.
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