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Octapharma USA: FDA Grants Orphan Drug Exclusivity to wilate®, the First VWF Concentrate for Prophylaxis in All Types of VWD


Octapharma USA, Inc. announced the U.S. Food and Drug Administration (FDA) has granted orphan drug exclusivity for 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).

The FDA Orphan Drug Designation program provides orphan status to biologics and drugs for rare diseases. 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 1% of the U.S. population, including many who are undiagnosed. Read More

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