Grifols recently announced that it received U.S. Food and Drug Administration (FDA) approval for revised labeling for Alphanate®, a plasma-derived factor product that contains both factor VIII (FVIII) and von Willebrand factor. The new approval states the specific steps that Grifols implements in the manufacturing process of Alpanate® to reduce the infectivity of an experimental TSE (transmissible spongiform encephalopathy) agent that is a model for variant Creutzfeldt Jakob Disease (vCJD).
TSEs such as vCJD are characterized by misshapen prion proteins that form spongelike holes in the brain tissue, causing a degenerative condition that is fatal. According to the release, the new labeling is the result of “extensive Grifols research” into the capacity for TSE experimental model agent. The research showed that heat treatment, solvent detergent and other enhanced techniques, already established as effective in eliminating other viruses, could also remove the experimental TSE agent. The data were published in the journal Haemophilia in 2009.
“Because of our history, the bleeding disorders community has a responsibility to be informed and vigilant about the safety of the medicines we take,” said Val Bias, CEO of the National Hemophilia Foundation. “It is encouraging to know that Grifols shares this responsibility with the community and is actively engaged in demonstrating the safety of its products.”
Alphanate® is indicated for the prevention and control of bleeding in patients with FVIII deficiency due to hemophilia A. It 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®) is either ineffective or contraindicated.
Source: PRNewswire, March 4, 2011