ADMA Biologics, Inc. has received FDA approval for Asceniv™, Immune Globulin Intravenous, Human–slra 10% Liquid, previously known as RI-002. The intravenous immune globulin product is for treatment of primary humoral immunodeficiency disease (PI) in adults and adolescents aged 12 to 17 years.
Asceniv Immune Globulin Intravenous, Human–slra 10% Liquid, is a plasma-derived, polyclonal, intravenous immune globulin IVIG containing polyclonal antibodies. These proteins are used by the immune system to neutralize microbes, such as bacteria and viruses, and prevent against infection and disease.
A pivotal phase 3 clinical study enrolled 59 patients with PI at nine U.S. sites who received regular infusions of Asceniv over one year. The primary endpoint evaluated the rate of serious bacterial infections (SBIs) in patients treated with the drug. During the 12-month study period, there were no SBIs.
The drug’s labeling will include a boxed warning about potential thrombosis and renal dysfunction or failure. The most common adverse reactions to ASCENIV™ were headache, sinusitis, diarrhea, viral gastroenteritis, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea.
ADMA Biologics anticipates that Asceniv will be available for commercial launch during the second half of 2019.
Source: ADMA Biologics, April 1, 2019