FDA approves hemophilia A drug

WASHINGTON, Oct. 13 (UPI) -- The U.S. Food and Drug Administration has approved a new use for the blood product Kogenate FS in children with the most severe form of hemophilia.

The FDA said Kogenate FS is meant to reduce the frequency of bleeding episodes and prevent joint damage in such children.

Hemophilia A is a rare, hereditary, bleeding disorder in which a protein needed to form blood clots, factor VIII, is missing or its level is reduced. The FDA said the disorder affects about 15,000 individuals in the United States, nearly all of whom are male.

"Administering Kogenate FS to children with hemophilia 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 hemophiliacs," said Dr. Jesse Goodman, director of the agency's Center for Biologics Evaluation and Research.

The drug is a genetically engineered version of factor VIII and was first licensed in the United States in 1993 for use during surgery and to prevent or control other bleeding episodes.

Kogenate FS is manufactured by Bayer Healthcare LLC of Tarrytown, N.Y.