ADMA Biologics, Inc. receives U.S. Food and Drug Administration approval to expand ASCENIV use in primary immunodeficiency to children aged 2 years and older, following completion of pediatric studies.
Written By: Mahathi Palivela, PharmD
Reviewed By: Pharmacally Editorial Team
ADMA Biologics, Inc. has received approval from the U.S. Food and Drug Administration for a supplemental Biologics License Application (BLA) for ASCENIV, marking completion of the required pediatric post-marketing assessment.
The approval expands ASCENIV’s indication for the treatment of primary humoral immunodeficiency (PI), allowing its use in pediatric patients aged 2 years and older. Previously, the therapy was approved only for patients aged 12 years and above.
ASCENIV is a plasma-derived intravenous immune globulin (IVIG) composed of polyclonal antibodies. It is designed to support immune defense by neutralizing bacteria and viruses. The product uses ADMA’s proprietary plasma donor screening and pooling process, which incorporates plasma with high titers of respiratory syncytial virus (RSV) antibodies.
Adam Grossman, President and Chief Executive Officer of ADMA stated that the label expansion enables earlier treatment intervention in younger immunocompromised patients, supporting broader clinical use of the therapy. He added that the company aims to increase access to its immune globulin product in pediatric populations.
Kaitlin Kestenberg Chief Operating Officer and Senior VP of Compliance acknowledged the role of patients, families, and clinicians in completing the pediatric studies. She noted that the approval reflects successful clinical execution and collaboration across the PI community.
ASCENIV was initially approved by the FDA in April 2019 for the treatment of primary immune deficiency disease (PIDD). With this updated labeling, ADMA strengthens its position in the immunoglobulin market by addressing treatment needs in younger patients with immune deficiencies.
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About the Writer
Mahathi Palivela is pursuing PharmD and has a strong interest in Clinical Pharmacy and Patient safety. She is passionate about handling and analyzing patient data, and translating clinical insights into clear, meaningful summaries. She aims to apply this interest in Medical Writing and Pharmacovigilance, focusing on improving patient outcomes through careful data interpretation and communication .