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

2024-04-29

孤儿药

Patients with severe VWD are recommended to utilize long-term prophylaxis with VWF concentrate

FDA provides wilate® with up to seven years of market exclusivity for approved prophylaxis indication

PARAMUS, N.J., April 29, 2024 /PRNewswire/ -- 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).

来源: PRNewswire

Octapharma USA announced the U.S. Food and Drug Administration has granted orphan drug exclusivity for wilate®, for routine prophylaxis to reduce the frequency of bleeding episodes in adults and children 6 years of age and older with von Willebrand disease.

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