Grifols, a leader in the production of plasma-derived medicines, announces the launch of a 2000 IU/vial assay size for ALPHANATE. ALPHANATE is indicated for the control and prevention of bleeding in patients with Hemophilia A and for surgical and/or invasive procedures in adult and pediatric patients with von Willebrand disease in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with sever VWD (Type 3) undergoing major surgery.
With the launch of the new 2000 IU FVIII ALPHANATE assay, Grifols will now supply the largest FVIII and von Willebrand Factor:Ristocetin Cofactor (VWF:RCo) assay available on the market for any plasma-derived FVIII concentrate. The higher potency allows patients who previously used a 1500 IU assay to reduce their potential total administration time by 30% every day.
“This higher potency offers a significant advantage to Hemophilia A patients that require high dose therapy,” said Joel Abelson, President of North American Commercial Operations. “Since the approval of the 2000 IU FVIII assay, ALPHANATE has twice the factor and half the volume of any other FVIII/VWF complex product. The larger assay may help patients decrease their overall infusion time and will reduce the total volume needed for a high dose infusion.”
The 2000 IU FVIII ALPHANATE assay will be available October 1, 2014.
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