FDA
FDA expands Asceniv label to younger children with primary immunodeficiency
Image source: ADMA Biologics
The FDA has approved a supplemental biologics license application expanding the indication for Asceniv (immune globulin human-slra) to include pediatric patients with primary humoral immunodeficiency (PI) aged 2 years and older. Previously, Asceniv was limited to patients aged 12 and up.
The approval fulfills a postmarketing pediatric assessment and reflects completion of the final study report, enabling clinicians to use Asceniv earlier in the treatment journey for younger immune‑compromised patients. Asceniv is a plasma‑derived, polyclonal IVIG distinguished by a patented donor screening and plasma pooling process that includes respiratory syncytial virus (RSV)–enriched plasma.
In clinical use, Asceniv has demonstrated a safety profile consistent with other IVIG products. The most common adverse reactions (≥5% of patients) included headache, sinusitis, diarrhea, viral gastroenteritis, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea. As with all IVIGs, boxed warnings include risks of thrombosis and renal dysfunction, particularly in patients with pre‑existing risk factors, underscoring the importance of appropriate dosing, infusion rates, and monitoring.
The expanded approval addresses "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.
Source: ADMA Biologics. (2026, May 4). Press release. ADMA Biologics Announces FDA Approval to Expand the Label for ASCENIV to Include Pediatric Immune Compromised Patients Two Years of Age and Older