ADMA Biologics announced that the Food and Drug Administration (FDA) has approved Asceniv (immune globulin intravenous [human] – slra) 10% Liquid for the treatment of primary humoral immunodeficiency disease (PIDD) in patients aged ≥12 years.

Asceniv is an intravenous immune globulin (IVIG) derived from human plasma containing naturally occurring polyclonal antibodies (e.g., Streptococcus pneumoniae, Haemophilus influenzae type B, cytomegalovirus, measles, tetanus, etc.) as well as plasma from donors tested to have high levels of neutralizing antibodies to respiratory syncytial virus (RSV).

The product was evaluated in a phase 3 study (N=59) where patients with PIDD received regular infusions of Asceniv over 1 year. The primary endpoint of the study was the rate of serious bacterial infections (SBI) in patients who received Asceniv; secondary endpoints included time to first SBI and first serious infection, days on antibiotics, days off school or work due to infections, all confirmed infections of any kind, and hospitalizations due to infection.

Results showed zero SBIs during the 1-year study period. In addition, secondary outcomes were found to be comparable to those seen with other IVIG products.

The most common adverse reactions identified in the study included headache, sinusitis, diarrhea, viral gastroenteritis, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea. Asceniv carries a Boxed Warning regarding the potential for thrombosis and renal dysfunction/failure.

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“Asceniv is manufactured using our unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and plasma from donors tested using our proprietary microneutralization assay,” said Adam Grossman, President and CEO of ADMA Biologics. “Going forward, we believe this FDA approval better positions ADMA to further its mission to evaluate Asceniv in immune-compromised patients infected with or at-risk for respiratory syncytial virus (RSV) infection.”

Asceniv is anticipated to launch in the second half of 2019.

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