FDA OKs Wilate for Hemophilia A in Adults, Adolescents
Wilate, a von Willebrand factor replacement therapy, was approved for use in patients with hemophilia A for routine prophylaxis and on demand treatment and control of bleeding episodes.
Officials with the FDA have approved Octapharma’s von Willebrand factor (VWF) replacement therapy, VWF/coagulation factor VIII complex (human) lyophilized powder for solution for intravenous injection (Wilate), for the treatment of adults and adolescents with hemophilia A, according to a company press release.
Wilate is a human plasma-derived, sterile, purified, double virus inactivated von Willebrand Factor (VWF)/coagulation Factor VIII (FVIII) complex. The therapy was initially approved in 2009 for adults and children with von Willebrand Disease (VWD) for on-demand treatment and control of bleeding episodes, and perioperative management of bleeding.
The approval of this indication extends Wilate’s use to hemophilia A to reduce the frequency of bleeding episodes and for on-demand treatment and control of bleeding episodes, according to Octapharma.
This application was approved based on a clinical study, which evaluated the efficacy and safety of Wilate in patients with hemophilia A with at least 150 previous exposure days to a FVIII concentrate. Patients in the study underwent prophylactic treatment with Wilate for 6 months and at least 50 exposure days. The results added to existing data used to support the approval for the hemophilia A indication.
Overall, a total of 136 previously-treated patients with hemophilia A received Wilate in 5 clinical studies involving prophylactic use, treatment on demand, surgery, and/or pharmacokinetics. The patients, all of whom were male, received 19,317,004 International Units (IUs) of Wilate during 9001 exposure days. The most common adverse event (AE) was pyrexia, and other AEs included pruritis, headache, and sleeping disorder.
“Octapharma has been committed to providing US hemophilia A patients with complete access to the company product portfolio since our inception,” Flemming Nielson, president of Octapharma USA, said in a statement. “We are excited for providers and patients who have been looking forward to the day when Wilate would be indicated for hemophilia A. Octapharma is dedicated to providing the bleeding disorders community with the therapies and programs that enhance patient lives every day.”
FDA Approves Octapharma's Wilate for Hemophilia A in Adult and Adolescent Patients [news release]. Octapharma. https://www.businesswire.com/news/home/20191008005749/en/. Accessed October 8, 2019.