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Grifols introduces 2000 FVIII IU ALPHANATE assay

Spanish producer of plasma-derived medicines Grifols has launched a 2000 IU/vial assay size for ALPHANATE (antihemophilic factor/von Willebrand factor complex [human]).

ALPHANATE is used to control and prevent bleeding in patients with Hemophilia A as well as for surgical and/or invasive procedures in adult and pediatric patients with von Willebrand disease in whom desmopressin (DDAVP) is either ineffective or contraindicated.

The drug is not indicated for patients with severe VWD (Type 3) undergoing major surgery.

The company 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.

Grifols North American Commercial Operations president Joel Abelson said this higher potency offers a significant advantage to Hemophilia A patients that require high dose therapy.

"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," Abelson said.

"The larger assay may help patients decrease their overall infusion time and will reduce the total volume needed for a high dose infusion."

According to the company, the 2000 IU FVIII ALPHANATE assay will be available from 01 October 2014.