Clinical Overview: Asceniv IVIG for Primary Humoral Immunodeficiency Disease

In 2019, the FDA granted approval to ADMA Biologics’ intravenous immune globulin (IVIG) drug product for the treatment of primary humoral immunodeficiency disease (PI) in adults and adolescents. Immune Globulin Intravenous, Human — slra 10% Liquid (Asceniv), is a plasma-derived polyclonal IVIG drug product designed to prevent serious bacterial infections (SBIs) in this patient population.

The approval was based on results from the phase 3 clinical study evaluating 59 patients with PI at 9 sites across the United States. For the study, patients received regular infusions of Asceniv over the course of 1 year. According to the study, there were no SBIs during the 12-month study period in treated patients.

The most common adverse effects reported during the study were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea. The approved labeling includes a boxed warning about potential thrombosis and renal dysfunction or failure.

According to ADMA Biologics, Asceniv is manufactured using its unique, patented plasma donor screening methodology and tailored plasma pooling design, blending normal source plasma and plasma from donors tested using its proprietary microneutralization assay.