The FDA has approved RiaSTAP(purified fibrinogen concentrate, from CSL Behring) for the treatment of acutebleeding episodes in patients with congenital fibrinogen deficiency, includingafibrinogenemia and hypofibrinogenemia. 

The approval is based on a phaseII, open-label study which showed median fibrinogen plasma antigen levels andmedian fibrinogen plasma activity levels reached a maximum within 30 minutes(antigen) to 1 hour (activity) post-infusion and decreased continuouslyafterward. Study results also demonstrated a highly significant (p<0.0001)mean improvement in maximum clot firmness (MCF) from baseline to 1 hourpost-infusion following RiaSTAP treatment. 

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