FDA Approves Drug to Prevent Joint Damage in Children with Haemophilia A

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Title: FDA Approves Drug to Prevent Joint Damage in Children with Haemophilia A
URL: http://www.pslgroup.com/dg/22E8AA.htm
Doctor's Guide
October 10, 2008

ROCKVILLE, Md -- October 10, 2008 -- The US Food and Drug Administration (FDA) has approved a new use for antihemophilic factor recombinant (Kogenate FS) to reduce the frequency of bleeding episodes and prevent joint damage in children with haemophilia A.

"Administering [the drug] 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," said Jesse Goodman, MD, FDA's Center for Biologics Evaluation and Research, Rockville, Maryland.

In a clinical trial, 65 boys aged less than 30 months with severe haemophilia A and normal joints were observed for 5 years. The patients received either 1 daily dose of the drug or 3 doses at the time of a bleeding episode.

Joint damage during a bleeding episode was 6-fold lower, and the rate of bleeding 8-fold lower, in those boys who received the drug on a daily basis compared with those who received the drug only when a bleeding episode occurred. Most patients received the drug intravenously through a catheter.

The most common adverse events were infection at the catheter site and fever.

SOURCE: US Food and Drug Administration

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