Alphanate Labeling Revised to Include Reduced Infectivity of an Experimental Model Agent for vCJD

Grifols announced that the FDA has approved revised labeling for Alphanate (antihemophilic Factor/von Willebrand Factor Complex [human]) indicating that certain manufacturing steps have been shown to reduce the infectivity of an experimental transmissible spongiform encephalopathy (TSE) agent that is a model for variant Creutzfeldt-Jakob Disease (vCJD). Because Alphanate is made from pooled human plasma, it may carry a risk of transmitting infectious agents (eg, viruses) and theoretically, the CJD agent. Grifols has implemented specific manufacturing steps with infectivity reduction capacity, including polyethylene glycol precipitation, affinity chromatography and saline precipitation. The combined effect of the production steps provided an imputed reduction capacity of 8 log10 of the experimental CJD/vCJD agent.

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 surgery, in whom desmopressin (DDAVP; sanofi-aventis) is either ineffective or contraindicated.

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