January 20, 2009
RiaSTAP available for acute bleeding episodesThe FDA has approved RiaSTAP (purified fibrinogen concentrate, from CSL Behring) for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
The approval is based on a phase II, open-label study which showed median fibrinogen plasma antigen levels and median fibrinogen plasma activity levels reached a maximum within 30 minutes (antigen) to 1 hour (activity) post-infusion and decreased continuously afterward. Study results also demonstrated a highly significant (p<0.0001) mean improvement in maximum clot firmness (MCF) from baseline to 1 hour post-infusion following RiaSTAP treatment.
For more information call (800) 504-5434 or visit www.RiaSTAP.com.