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The blood product kogenate FS has been approved for use in the US in reducing the frequency of bleeding episodes and preventing joint damage in children with the most severe form of haemophilia.
Haemophilia A is a rare, hereditary, bleeding disorder which affects mainly males. The disorder occurs when a protein needed to form blood clots, factor VIII, is missing or its level is reduced.
People with haemophilia bleed longer from injuries than those without haemophilia. This means that they often experience serious bleeding episodes, particularly in the joints and muscles. Repeated bleedings increase the chance of joint damage.
Kogenate FS is a genetically engineered version of factor VIII and was first licensed in the US in 1993 for use during surgery and to prevent or control other bleeding episodes.
Jesse Goodman, director of the Food and Drug Administration’s Centre for Biologics Evaluation and Research, said: “Administering Kogenate FS to children with haemophilia A on a daily basis before a bleeding event occurs will reduce bleeding into joints and help prevent joint damage, a major cause of disability in haemophiliacs.”
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