FDA approval allows ADMA Biologics to market its immune therapy ASCENIV for pediatric patients aged two and older, broadening its addressable market.
ADMA Biologics (NASDAQ:ADMA) secured FDA approval to expand the label for its immune therapy ASCENIV to include children aged two years and older. The treatment was previously limited to patients aged 12 and above with primary humoral immunodeficiency (PI).
The approval follows a post-marketing pediatric assessment and significantly broadens the therapy’s potential patient base. ASCENIV, a plasma-derived intravenous immune globulin, is protected by international patents and designed to help neutralize bacteria and viruses.
CEO Adam Grossman noted the milestone enables earlier intervention for younger immune-compromised patients. The company plans to prioritize ASCENIV’s use in pediatric care, leveraging its proprietary donor screening and plasma pooling methodology.