The US Food and Drug Administration (FDA) has approved wilate, the first and only replacement therapy developed specifically for von Willebrand disease (VWD), a bleeding disorder which affects around 1% to 2% of the US population.
Wilate is a newly developed, high-purity, double virus inactivated von Willebrand Factor/Coagulation Factor VIII Concentrate developed by Octapharma USA, which has demonstrated efficacy for all types of VWD, including paediatric patients in four prospective clinical trials.
Georgetown University Hospital, professor of medicine and pathology and director of the Division of Coagulation Craig Kessler said that FDA approval of wilate makes this the first and only replacement therapy developed and manufactured specifically for VWD.
"Its unique viral attenuation will provide a next-generation treatment option for patients with VWD," said Kessler.
Wilate is indicated for the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe VWD as well as patients with mild or moderate VWD.