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FDA Approves IV Immune Globulin, Bivigam, for Immunodeficiency
Safety and efficacy demonstrated in phase III study (Dec. 20)The FDA has approved Bivigam (Biotest Pharmaceuticals), a 10% liquid intravenous immune globulin (IVIG), for the treatment of patients with primary humoral immunodeficiency.
In a pivotal phase III, open-label trial –– published in the Journal of Clinical Immunology –– Bivigam successfully achieved its primary endpoints for safety, efficacy, and tolerability. In the study, a total of 63 patients with primary immunodeficiency were treated every 3 or 4 weeks with Bivigam infusions of 254 to 1,029 mg/kg (mean dose: 500 mg/kg) for approximately 1 year.
Fifty-nine patients (94%) reported at least one adverse event (AE). Of these patients, 40 (64%) were judged to have experienced an AE that was related to the study drug. Mild AEs occurred in 11 patients (18%); moderate AEs occurred in 21 patients (33%); and severe AEs occurred in 8 patients (13%). The most frequent severe, drug-related AEs were headache (three patients, 5%), migraine (two patients, 3%), and fatigue (two patients, 3%).
Two serious bacterial infections (SBIs) occurred during the study. Both patients were hospitalized. These two episodes resulted in an SBI rate of 0.035 SBI/patient/year –– substantially below the FDA’s target rate of = 1.0 SBI/patient/year.
The mean half-life of Bivigam was approximately 30 days.
Bivigam is a sugar-free, glycine-stabilized IVIG. The drug is available in 50-mL (5-gram) and 100-mL (10-gram) vials.