FDA grants orphan drug exclusivity approval for Octapharma AG's wilate

Jan 18 2010

Octapharma AG, one of the largest manufacturers of plasma products in the world, today announced that it has received orphan drug exclusivity approval for wilate® from the U.S. Food and Drug Administration (FDA). The approval was granted for the use of wilate® for the treatment of spontaneous or trauma-induced bleeding episodes in patients with severe von Willebrand disease (VWD) as well as in patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated.

The FDA's approval and granting of orphan drug exclusivity of wilate® marks the entrance of Octapharma USA into the U.S. blood coagulation market, with product availability scheduled for early 2010. Octapharma USA is the rapidly growing U.S. division of Octapharma AG

"The FDA orphan drug exclusivity approval for wilate® is an important aspect in Octapharma`s development of this drug," said Kim Bjornstrup, Vice Chairman Octapharma Group. "Orphan drug exclusivity confirms Octapharma's decision to focus exclusively on the treatment of von Willebrand patients. Wilate has a combination of two viral attenuation steps, high purity and a physiological 1:1 ratio of VWF and FVIII activity and is approved for treating all VWD patients including those with the most severe, type 3, disease."