ADMA Biologics announced US FDA approval of a supplemental Biologics License Application for Asceniv (immune globulin intravenous, human – slra 10% liquid), expanding its primary humoral immunodeficiency indication to include pediatric patients as young as two years of age. The approval lowers the minimum eligible age from 12 years, extending access to a population in which immunoglobulin replacement therapy has historically been managed with products from larger competitors.
The supplemental BLA revises Asceniv’s prescribing information to cover adults and pediatric patients two years of age and older with primary humoral immunodeficiency. The FDA characterized the approval as fulfilling a post-marketing commitment, with the submission representing the final study report from the pediatric assessment program ADMA was required to complete following the drug’s original approval in April 2019.
Asceniv is a plasma-derived, polyclonal intravenous immune globulin manufactured using a proprietary plasma donor screening methodology that blends normal source plasma with plasma collected from donors with elevated respiratory syncytial virus-neutralizing antibody titers, identified through a microneutralization assay. That manufacturing approach, which ADMA holds patents on, is the basis on which the company differentiates Asceniv from other intravenous immunoglobulin products in the primary humoral immunodeficiency space.
The clinical evidence supporting the pediatric label expansion was generated through a dedicated pediatric study required as a post-marketing commitment, evaluating Asceniv in patients between two and 11 years of age with primary humoral immunodeficiency. The program assessed pharmacokinetics, safety, and tolerability in this younger cohort. Specific efficacy and safety data from the final study report were not disclosed in the company’s announcement, though the FDA’s acceptance of the supplemental BLA confirms the data package met the regulatory threshold for label revision.