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US FDA panel to review bleeding, thrombosis products

This article was originally published in Scrip

Executive Summary

TheUS FDA's blood products advisory panel willmeet on January 9th to discussCSL Behring's BLA for plasma-derived fibrinogen concentrate for the treatment of bleeding in patients with congenital fibrinogen deficiency. Later the same day the experts will discuss GTC Biotherapeutics' BLA for ATryn (recombinant antithrombin III) for patients with hereditary antithrombin deficiency to prevent thrombosis during high-risk surgical and obstetrical procedures. ATryn is produced from the milk of transgenic goats. Ovation Pharmaceuticalslicensed the US rights from GTC in August. The product has orphan status and is undergoing a priority review, with a February user fee date.



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