FDA Approves New von Willebrand Disease Product
Last month Octapharma USA announced that the U.S. Food and Drug Administration (FDA) had approved Wilate®, an injectable human-derived von Willebrand factor (VWF)/factor VIII (FVIII) concentrate for the treatment of spontaneous and trauma-induced bleeding episodes in patients with all types of von Willebrand disease (VWD). Wilate® is also indicated for the treatment of patients with mild or moderate VWD in whom the use of desmopressin (a synthetic version of the hormone vasopressin) is ineffective or contraindicated.
According to Octapharma, Wilate® is the first double virus inactivated VWF/FVIII, high-purity concentrate. A solvent/detergent process and a special dry-heating system are used in manufacturing. The PermaHeat process inactivates both enveloped and nonenveloped viruses. Wilate® is exclusively derived from large pools of human plasma collected in FDA-approved plasma donation centers in the U.S.
"The FDA approval of Wilate® makes this the first and only replacement therapy developed and manufactured specifically for VWD. Its unique viral attenuation steps and it's close to 1:1 ratio of FVIII and VWF will provide a next generation treatment option for patients with von Willebrand disease", said Craig Kessler, MD, Georgetown University Hospital, Professor of Medicine and Pathology and Director of the Division of Coagulation. Kessler is also the Chair of the National Hemophilia Foundation's Medical and Scientific Advisory Council.
Octapharma USA is based in Hoboken, New Jersey. It is a division of Octapharma AG of Lachen, Switzerland, one of the largest plasma product manufacturers worldwide.
Source: PR Newswire, December 7, 2009