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news.Grifols has received approval from the FDA to market Alphanate for the treatment of the bleeding disorder von Willebrand disease, in connection with surgery or other invasive procedures.
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Alphanate is the first and only dual inactivated and affinity chromatography purified antihemophilic factor/von Willebrand factor complex that is FDA approved for the treatment of von Willebrand disease (VWD).
Dual inactivated Alphanate has been proven safe and effective for the treatment of hemophilia A through more than a decade of use.
Grifols obtained FDA approval for the use of Alphanate in the treatment of VWD on the basis of prospective and retrospective clinical data to evaluate the safety and efficacy of the therapy. Clinical data from 76 patients was submitted in support of the VWD indication for Alphanate. The company has committed to conducting post-market studies to collect additional clinical data on the safety and efficacy in treating severe VWD.
Grifols acquired the product license for Alphanate in 2003 from AlphaTherapeutic Corporation along with other assets and manufacturing facilities.
Von Willebrand disease is a bleeding disorder caused by a defect or deficiency of a blood clotting protein called von Willebrand factor. Von Willebrand factor is a protein necessary in the initial stages of blood clotting.