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 now include room temperature (25°C) storage conditions for up to 4 weeks during the first 24 months of the 36-month approved shelf life.
The new room temperature storage condition 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.
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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 today’s announced approval, the Company anticipates reaching more customers otherwise inaccessible due to limited refrigeration space and cold chain capacity constraints; this approval meaningfully alleviates these supply chain restrictions,” said Adam Grossman, President and CEO of ADMA. “The approval of room temperature storage for Asceniv and Bivigam is a meaningful enhancement of each product’s go-to market offering as it should provide for more versatile utilization and inventory management by providers.”
Reference
ADMA Biologics announces FDA approval for room temperature storage of Asceniv™ & Bivigam®. News release. ADMA Biologics. Accessed December 13, 2022. https://www.globenewswire.com/news-release/2022/12/13/2572541/33130/en/ADMA-Biologics-Announces-FDA-Approval-for-Room-Temperature-Storage-of-ASCENIV-BIVIGAM.html.
This article originally appeared on MPR
