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UPDATED: Study Shows New Drug Superior to Plasma for Warfarin Reversal

December 10, 2013; Posted by: webleed staff

CSL Behring’s Kcentra, the first non-activated 4-factor prothrombin complex concentrate, was approved by the Food and Drug Administration in April 2013 for the urgent reversal of warfarin therapy in adult patients with acute major bleeding.

Is there a new drug that could ultimately be superior to human plasma in the case of surgical bleeding in adults? A new study presented by CSL Behring at the American Society of Hematology (ASH) Annual Meeting this past weekend showed Kcentra was superior to plasma, the current standard of care in the U.S., in adult patients taking vitamin K antagonist therapy (warfarin) who required warfarin reversal prior to an urgent surgery or invasive procedure.

“The data demonstrated a strong benefit for Kcentra over plasma for patients on VKAs requiring an urgent surgery or invasive procedure,” said Majed Refaai, M.D., Associate Professor, Department of Pathology and Laboratory Medicine, University of Rochester Medical Center. “These data suggest that Kcentra may offer a valuable advance to help physicians and other healthcare professionals rapidly restore coagulation factors and help prevent excessive bleeding in patients on warfarin who require an urgent surgery or intervention, a population highly susceptible to serious and life-threatening bleeds.”

Whenever a new advancement can prevent bleeding of any kind, major or minor, webleed is big fan of it! To read more about the Kcentra study at ASH, click the Wall Street Journal link.

Always an exciting time in the bleeding/clotting disorders community when there are new drug and therapy advancements . Click the link to read more about CSL Behring.

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UPDATE: December 16, 2013
The FDA has approved the expanded indication for Kcentra (CSL Behring) to include the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy in adult patients needing an urgent surgery or other invasive procedure.
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Photo Credit – CSL Behring 

webleed.org – your source for bleeding news!

3 Comments

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