January 20, 2009

RiaSTAP OK’d for genetic bleeding defect

The U.S. Food and Drug Administration has approved RiaSTAP for the treatment of bleeding in patients with a rare genetic defect.

People with the defect -- congenital fibrinogen deficiency -- are unable to make sufficient amounts of fibrinogen, which plays an important role in blood coagulation by helping to form blood clots and prevent bleeding.

This product offers much-needed treatment for the small number of patients with congenital fibrinogen deficiency, said Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research. If bleeding occurs in the brain or other organs and is left untreated, it may lead to blood loss, organ damage and death.

The FDA said RiaSTAP is an intravenous fibrinogen concentrate made from the plasma of healthy human blood donors.

The product is produced by CSL Behring of Marburg, Germany.