ADMA Biologics has announced that the US FDA has approved its supplemental Biologics License Application for ASCENIV, expanding the drug’s use to include pediatric patients with primary humoral immunodeficiency.
The decision broadens access beyond the previous label, which limited treatment to patients aged 12 and above, marking a significant expansion for immune-compromised children who rely on intravenous immunoglobulin therapies.
The FDA approval also completes the required pediatric post-marketing study commitment tied to ASCENIV’s original licensure.
“This expanded label for ASCENIV allows ADMA to actively address the treatment needs of younger PI and immune compromised patients earlier in their treatment journey,” said Adam Grossman, President and Chief Executive Officer of ADMA.
He added, “In the periods ahead, we look forward to continuing to expand the utilization of ASCENIV by offering our differentiated and patented immune globulin as an FDA-approved treatment option for immune compromised pediatric patients in need.”
Company leadership also emphasized the role of clinical collaborators and families in completing the pediatric program.
“We proudly recognize the extraordinary collaboration of the PI disease community and dedicated physicians, along with the courage and commitment of the children and families whose participation was essential in driving this clinical program forward,” said Kaitlin Kestenberg, Chief Operating Officer and Senior VP of Compliance.
“Enrolling in and successfully completing these complex trials is a significant achievement, and this FDA approval reflects the strength of the clinical and operational execution of the devoted ADMA team.”
ASCENIV is an intravenous immune globulin therapy derived from human plasma and is designed to help patients with weakened immune systems fight infections.
