FDA Grants wilate Orphan Drug Exclusivity

The U.S. Food and Drug Administration (FDA) has granted orphan drug exclusivity for Octapharma’s wilate, von Willebrand factor/coagulation factor VIII complex (human) lyophilized powder for solution for intravenous injection, for routine prophylaxis to reduce the frequency of bleeding episodes in adults and children 6 years of age and older with von Willebrand disease (VWD). Wilate is the first von Willebrand factor (VWF) concentrate indicated for prophylactic treatment across all forms of VWD, a significant patient treatment milestone for the most prevalent bleeding disorder in the United States. VWD affects up to one percent of the U.S. population, including many who are undiagnosed. 

“The FDA orphan exclusivity is exciting news for Octapharma and patients who have endured excessive bleeding episodes,” said Octapharma USA President Flemming Nielsen. “Patients with severe VWD are recommended to utilize long-term prophylaxis with VWF concentrate, as compared to on-demand treatment for bleeding, to avoid life-threatening bleeding episodes, as well as a better quality of life.”