Biotest announced that the FDA has approved Bivigam (immune globulin intravenous [human] 10% liquid) for the treatment of patients with primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

The approval was based on a Phase 3, open-label, multicenter study in 63 patients with PI or deficient antibody production prior to IgG replacement therapy. Patients were treated every 3 or 4 weeks with 300–800mg/kg of IVIG for one year. Patients were monitored for adverse events and serious adverse events during and between infusions. The primary efficacy endpoint was demonstration that the rate of acute serious bacterial infections was <1.0 per person-year during regular administration of investigational IVIG for 12 months. The study achieved its primary endpoints for safety, efficacy, and tolerability.

Bivigam is a polyspecific intravenous immune globulin. The broad spectrum of neutralizing IgG antibodies against bacterial and viral pathogens and their toxins helps to avoid recurrent serious opportunistic infections.

Bivigam will be available in a 10% liquid and supplied in 50mL and 100mL vials. Biotest plans to begin commercial shipments shortly.

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