FDA approves Bivigam (Biotest Pharmaceuticals Corporation) for Primary Humoral Immunodeficiency

The FDA has given Biotest Pharmaceuticals Corporation approval for Bivigam for the treatment of patients with Primary Humoral Immunodeficiency. Approval is based on a pivotal clinical study which successfully achieved its primary endpoints for safety, efficacy and tolerability. The results were recently published in the Journal of Clinical Immunology (Wassermann RL, Church JA, Stein M, et al. "Safety, efficacy and pharmacokinetics of a new 10% liquid intravenous immunoglobulin (IVIG) in patients with primary immunodeficiency." Journal of Clinical Immunology, August 2012, Volume 32, Issue 4, pp 663). This product is being produced for patients in the United States, and the company plans to begin commercial shipments shortly.