Octapharma AG, one of thelargest manufacturers of plasma products in the world, has received orphan drug exclusivity approval for wilate from the FDA. The approval was granted for the use of wilatefor the treatment of spontaneous or trauma-induced bleeding episodes inpatients with severe von Willebrand disease (VWD) as well as in patients withmild or moderate VWD in whom the use of desmopressin is known or suspected tobe ineffective or contraindicated. The FDA’s approval and granting of orphan drug exclusivity of wilatemarks the entrance of Octapharma USA into the U.S. blood coagulation market,with product availability scheduled for early 2010. Octapharma USA is therapidly growing U.S. division of Octapharma AG. “The FDA orphan drug exclusivity approval for wilate is an importantaspect in Octapharma’s development of this drug,” said Kim Bjornstrup, ViceChairman Octapharma Group. “Orphan drug exclusivity confirms Octapharma’sdecision to focus exclusively on the treatment of von Willebrand patients.Wilate has a combination of two viral attenuation steps, high purity and aphysiological 1:1 ratio of VWF and FVIII activity and is approved for treatingall VWD patients including those with the most severe, type 3, disease.”
