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Octapharma Receives Orphan Drug Exclusivity Approval for wilate(R) - A Replacement Therapy Developed Specifically for von Willebrand Disease
Date:1/13/2010

asma collected in U.S. FDA approved plasma donation centers and no albumin is added as a stabilizer.

Four prospective clinical trials have demonstrated the safety, tolerability and hemostatic efficacy of wilate® in the treatment of acute bleeding episodes in patients with various types of VWD. Using objective and subjective criteria, treatment with wilate® was observed in 1,068 bleeding episodes and determined to be successful between 84% and 93% with results varying dependent on patient type.(2)

Since the mid-1980s, the requirements for the viral safety of plasma preparations have constantly become more stringent, requiring demonstrated virus elimination/inactivation (3) (4). Several viral inactivation steps have enhanced the safety of coagulation products, but S/D inactivation is the current gold standard for safety from highly infectious enveloped viruses (5). In the 1980s Octapharma was the first manufacturer to apply the S/D inactivation to a large-scale production of plasma derivatives. The wilate® manufacturing process provides two independent and effective virus inactivation procedures, namely S/D treatment in bulk and TDH treatment of the lyophilized product in final container. In addition, the ion-exchange chromatography step utilized during wilate® manufacturing contributes to the viral safety.

Because human plasma contains VWF and FVIII at very low concentration, the wilate® manufacturing process is designed to concentrate the proportion of VWF/FVIII complex while minimizing the inclusion of extraneous proteins. Accompanying plasma proteins that may give rise to clinical side-effects, as well as proteases that could impair the stability of coagulation factors and degrade their natural structure and functionality, are efficiently removed during production.

Important Safety Information

There is a possibility that wilate® can cause hypersensitivity or allergi
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SOURCE Octapharma AG
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1. Octapharma USA Announces FDA Approval of wilate(R) - the First Replacement Therapy Developed Specifically for von Willebrand Disease
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