Posted by Michael Wonder on 08 Oct 2019
FDA approves Octapharma’s Wilate for haemophilia A in adult and adolescent patients
8 October 2019 - Octapharma USA today announced the U.S. FDA has approved Wilate for treatment of adults and adolescents with haemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and on demand treatment and control of bleeding episodes.
Wilate is a human plasma-derived, sterile, purified, double virus inactivated von Willebrand Factor (VWF)/coagulation Factor VIII (FVIII) complex initially approved by the FDA in 2009 for children and adults with von Willebrand Disease (VWD) for on-demand treatment and control of bleeding episodes; and peri-operative management of bleeding.
The FDA approved Octapharma’s application to add the haemophilia A indication based on the results of the “Clinical Study to Investigate the PK, Efficacy, and Safety of Wilate in Patients With Severe Hemophilia A,” (ClinicalTrials.gov Identifier: NCT02954575).
