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news.Octapharma has received orphan drug exclusivity approval for Wilate from the FDA. The approval was granted for Wilate's use in 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.
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Octapharma said that the FDA’s approval and granting of orphan drug exclusivity of Wilate marks the entrance of the company into the US blood coagulation market, with product availability scheduled for early 2010.
Kim Bjornstrup, vice chairman of Octapharma Group, said: “The FDA orphan drug exclusivity approval for Wilate is an important aspect in Octapharma`s development of this drug. 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.”