The FDA has approved Octapharma’s Wilate for Hemophilia A in adolescent and adult patients.
Wilate is a human plasma-derived, sterile, purified, double virus-inactivated Von Willebrand Factor (VWF)/Coagulation Factor VIII Complex (FVIII) in a lyophilized powder solution for intravenous injection. The product was originally approved in 2009 to control bleeding episodes on-demand and in perioperative settings.
“Octapharma has been committed to providing U.S. hemophilia A patients with complete access to the company product portfolio since our inception,” said Octapharma USA President Flemming Nielsen 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.”
The new approval is based upon results from the clinical trial NCT02954575. The single-group assignment test included 55 male participates aged 12 years and older with severe hemophilia, previous treatment with FVIII concentrate, and immunocompetence. The primary endpoint for the study was the reduction of total annualized bleeding rate; researchers observed a 50% reduction in the totally annualized bleeding rate and a total of 58.1 BEs per patient per year.
According to a press release, 136 patients with Hemophilia A between the ages of 11 to 66 received Wilate in five clinical studies involving prophylactic use, treatment on demand, surgery, and/or pharmacokinetics.
Wilate is contraindicated in patients with known hypersensitivity reactions (anaphylactic or severe systemic) to human-derived products, Wilate’s formulation, or container components.
Warnings issued with the use of Wilate include thromboembolic events; the development of neutralizing antibodies to FVIII and VWF, especially in VWD type III patients; and the potential for infections agent transmission due Wilate’s human plasma origins.
Adverse reactions reported with the use of Wilate include hypersensivity reactions, urticaria, and dizziness.