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FDA Approves Revised Alphanate® Labeling to Include Reduced Infectivity of an Experimental Model Agent for vCJD
Date:3/4/2011

onal Hemophilia Foundation. "It is encouraging to know that Grifols shares this responsibility with the community and is actively engaged in demonstrating the safety of their products," continued Mr. Bias.

In 2007 Alphanate® became the first dual virus inactivated (heat treatment and solvent detergent) and affinity chromatography purified clotting factor complex approved for the treatment of von Willebrand Disease (VWD) and hemophilia A. Some of the same manufacturing processes that are proven effective at eliminating viruses also have demonstrated the ability to remove the CJD/vCJD experimental agent. Specific manufacturing steps with infectivity reduction capacity include polyethylene glycol precipitation, affinity chromatography and saline precipitation.

Grifols' research used two different experimental agent preparations as well as Western blot and bioassay detection methods.  Validated scale models of the production steps for both Alphanate® and Grifols' Fanhdi® (FVIII/VWF complex product marketed outside the United States) were used in the studies.  The combined effect of the production steps provided an imputed reduction capacity of 8 log10 of the experimental CJD/vCJD agent.  

(1) DIEZ, J. M., CABALLERO, S., BELDA, F. J., OTEGUI, M., GAJARDO, R. and JORQUERA, J. I.  Elimination capacity of a TSE-model agent in the manufacturing process of Alphanate®/Fanhdi®, a human factor VIII/VWF complex concentrate. Haemophilia 2009, 15: (6), 1249-1257.

About Alphanate®

Antihemophilic Factor/von Willebrand Factor Complex (Human), Alphanate®, is indicated for the prevention and control of bleeding in patients with Factor VIII deficiency due to hemophilia A.  Alphanate®, is also indicated for surgical and/or invasive procedures in adult and pediatric patients with von Willebrand Disease, except Type III undergoing major sur
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