US FDA grants accelerated approval to CSL Behring Factor XIII drug
This article was originally published in Scrip
Executive Summary
The US FDA granted accelerated approval to CSL Behring's Corifact as the first therapy in the US to treat congenital Factor XIII deficiency, a rare genetic condition in which patients' bodies are unable to generate enough Factor XIII, the protein responsible for stabilizing the formation of a blood clot. Factor XIII deficiency is the rarest of all factor deficiencies, affecting about one in every five million births. The deficiency may lead to soft tissue bruising, mucosal bleeding and fatal intracranial bleeding in children and adults, with newborns also experiencing umbilical cord bleeding.