FDA Approves Novel Intravenous Immune Globulin Treatment
The FDA granted approval to ADMA Biologics’ intravenous immune globulin (IVIG) drug product for use in the treatment of primary humoral immunodeficiency disease (PI) in adults and adolescents, according to a company press release.
Immune Globulin Intravenous, Human – slra 10% Liquid (Asceniv), formerly referred to as RI-002, is a plasma-derived polyclonal IVIG drug product designed to prevent serious bacterial infections (SBIs) in this patient population.
PI is a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system. According to the American Academy of Allergy, Asthma, and Immunology, researchers have identified more than 300 different kinds of PI. PI includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency, X linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. Patients with PI are more susceptible to infections and more likely to have complications from these infections.
The approval is 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 Immune Globulin Intravenous, Human – slra 10% Liquid 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 will include a boxed warning about potential thrombosis and renal dysfunction or failure.
“We are excited about this significant achievement in receiving FDA approval for Asceniv, a novel, patented IVIG product that we feel is a necessary addition to existing available therapies for patients who suffer from PI,” Adam Grossman, president and chief executive officer of ADMA Biologics said in a prepared statement. “We hope availability of Asceniv will ameliorate a portion of the current shortages facing US IVIG supply.”
According to ADMA Biologics, Immune Globulin Intravenous, Human – slra 10% Liquid 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.
The company expects the product to be available for commercial launch during the second half of 2019, according to the release.
FDA Approves Asceniv, a Novel Intravenous Immune Globulin [news release]. ADMA Biologics. https://ir.admabiologics.com/press-releases/detail/434/fda-approves-asceniv-a-novel-intravenous-immune-globulin. Accessed April 2, 2019.