FDA expands ASCENIV label to include pediatric patients aged 2 years and older

The FDA has approved a label expansion for ASCENIV (immune globulin intravenous, human – slra 10% liquid; ADMA Biologics), extending its indication to include pediatric patients aged 2 years and older with primary humoral immunodeficiency (PI), according to an announcement from ADMA Biologics.

The approval follows submission of a supplemental Biologics License Application (BLA) and represents completion of a required pediatric postmarketing assessment. Previously, ASCENIV was indicated for patients aged 12 years and older with PI.

Expanded indication addresses earlier treatment needs

With this update, clinicians may now consider ASCENIV for younger pediatric patients with PI, a population at increased risk for recurrent infections due to impaired antibody production. The revised prescribing information reflects this broader age range, potentially enabling earlier intervention in the disease course.

“This expanded label for ASCENIV allows ADMA to actively address the treatment needs of younger PI and immunocompromised patients earlier in their treatment journey,” said Adam Grossman, president and CEO of ADMA. “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 immunocompromised pediatric patients in need.”

Product profile and mechanism

ASCENIV is a plasma-derived, polyclonal intravenous immune globulin (IVIG) designed to provide passive immunity through a broad range of antibodies. The product is manufactured using a proprietary plasma donor screening method and plasma pooling approach that incorporates both standard source plasma and respiratory syncytial virus (RSV)–enriched plasma.

The formulation contains naturally occurring antibodies that support immune defense against bacterial and viral pathogens. ASCENIV was initially approved by the FDA in April 2019 for the treatment of PI.

Clinical development supported by pediatric participation

Company leadership emphasized the role of clinical trial participants and investigators in achieving the expanded indication.

“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 vice president 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.”

Safety considerations remain consistent with IVIG class

The safety profile of ASCENIV is consistent with other IVIG products. The prescribing information includes a boxed warning for thrombosis and renal dysfunction, including acute renal failure. Risk factors for thrombosis include advanced age, prolonged immobilization, hypercoagulable states, and cardiovascular risk factors.

Clinicians are advised to use the minimum effective dose and infusion rate in at-risk patients and to ensure adequate hydration prior to administration. Monitoring for signs of thrombosis and renal impairment is recommended.

Common adverse reactions reported in at least 5% of study participants include headache, sinusitis, diarrhea, viral gastroenteritis, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea.

Implications for clinical practice

The expanded indication may influence treatment planning for pediatric patients with PI by providing an additional IVIG option for children as young as 2 years. Earlier access to immune globulin therapy may help reduce infection burden and support disease management in this population.

As with other IVIG therapies, patient selection, monitoring, and risk mitigation remain central to safe administration.

Reference

ADMA Biologics, Inc. ADMA Biologics announces FDA approval to expand the label for ASCENIV to include pediatric immune compromised patients two years of age and older. News release. May 4, 2026. Accessed May 4, 2026.https://ir.admabiologics.com/news-releases/news-release-details/adma-biologics-announces-fda-approval-expand-label-ascenivtm