FDA approves new use of drug in patients with hemophilia A

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Old 10-22-2008, 12:14 AM
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FDA approves new use of drug in patients with hemophilia A



HemOnc Today

October 13, 2008

Last week, the FDA approved the new use of an antihemophilic factor (recombinant), allowing the drug to be used in reducing the frequency of bleeding episodes and in preventing joint damage in children with hemophilia A.

Kogenate FS (Bayer Healthcare), a genetically engineered version of factor VIII, was originally licensed in the United States in 1993 for surgical use and the prevention or control of bleeding episodes, according to a press release.

The researchers conducted a clinical trial to investigate the use of the drug in children with hemophilia A. They enrolled 65 boys aged younger than 30 months who had severe hemophilia A and normal joints. During five years, the patients received either one daily dose of Kogenate FS or three doses at the time of a bleeding episode.

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Old 11-06-2008, 06:28 AM
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antihemophilic factor, hemophilia, hemophilia a, kogenate fs, recombinant


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