(dailyRx)

Octapharma USA has announced the FDA has approved Wilate for the treatment of spontaneous and trauma-induced bleeding episodes in patients with all types of von Willebrand disease (VWD).
Wilate is a newly developed, high-purity, double virus inactivated von Willebrand factor/coagulation factor VIII concentrate that demonstrated efficacy for all types of VWD, including pediatric patients, in four prospective clinical trials. The biological product is now approved to treat spontaneous and trauma-induced bleeding episodes in patients with severe VWD, as well as patients with mild or moderate VWD in whom the use of desmopressin (DDAVP, Stimate, Minirin) is known or suspected to be ineffective or contraindicated.

The first double virus inactivated von Willebrand factor/factor (VWF/FVIII), high-purity concentrate, Wilate is exclusively derived from large pools of human plasma collected in FDA-approved plasma donation centers.

The product will be available in early 2010.

VWD is a common bleeding disorder found in approximately 1 to 2 percent of the U.S. population, according to the Centers for Disease Control and Prevention. The illness is a result of the body's inability to make von Willebrand factor, the human protein that helps clot blood.

"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, M.D., of Georgetown University Hospital.

Four prospective clinical trials demonstrated the safety, tolerability and hemostatic efficacy of Wilate in treating acute bleeding episodes and prevention of bleeding episodes in patients with various types of VWD. Using objective criteria, Wilate was observed in 1,068 bleeding episodes and determined to be successful between 84 and 93 percent of the time, with results varying depending on patient type.

Contact:
Fred Feiner
908-894-3930
fred@yankeepr.com