FDA Extends Room Temperature Storage Conditions for Asceniv and Bivigam

The Food and Drug Administration (FDA) has approved the supplemental Biologics License Applications for both Asceniv^™ (immune globulin intravenous [human] – slra) 10% liquid and Bivigam^® (immune globulin intravenous [human]) 10% liquid to extend the room temperature (25°C) storage conditions for up to 4 weeks at any point during the 36-month approved shelf life. 

Previously, these storage conditions were only approved during the first 24 months of shelf life. The approval for extended ambient storage conditions for Asceniv and Bivigam is immediately effective, and applies to all existing lots currently in the commercial supply chain and to future production.

Asceniv and Bivigam are indicated for the treatment of primary humoral immunodeficiency in adults and adolescents (12 to 17 years of age). Primary immunodeficiency includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. 

Asceniv is supplied as a liquid solution containing 10% IgG (100mg/mL) in a 50mL single-use vial. Bivigam is supplied as a liquid solution containing 10% IgG (100mg/mL) in a 50mL and 100mL single-use vial. 

“With the FDA-approved extension of room temperature storage conditions, the Company expects to reach more customers who were previously inaccessible due to limited refrigeration space and cold chain capacity constraints,” said Adam Grossman, President and CEO of ADMA. “We believe that this added storage flexibility for both Asceniv and Bivigam will meaningfully enhance our products’ market offerings, enabling more versatile utilization and better inventory management for providers.”