Posted by Michael Wonder on 23 Feb 2023
Octapharma USA requests FDA approval for wilate VWD prophylaxis supplement
23 February 2023 - Biologics license application supplement supported by study evaluating efficacy and safety of wilate prophylaxis in adults and children age six and older with all types of VWD.
Octapharma USA has submitted a biologics license application supplement to the US FDA to expand the approval of wilate, von Willebrand factor/coagulation factor VIII complex (human) lyophilised powder for solution for intravenous injection, to include routine prophylaxis to reduce the frequency of bleeding episodes in children and adults with any type of von Willebrand disease.
