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SEC filingADMA Biologics announced FDA approval expanding ASCENIV's label to pediatric patients aged 2 years and older with primary humoral immunodeficiency, previously limited to 12 years and older.
The FDA approval of ADMA Biologics' supplemental Biologics License Application for ASCENIV represents a significant expansion of its indicated patient population, now including pediatric patients with primary humoral immunodeficiency aged two years and older, compared to the previous limitation of 12 years and older. This milestone completes the required post-marketing pediatric assessment, potentially broadening market access and utilization earlier in patients' treatment journeys. Management highlighted the collaboration with the PI disease community and physicians, as well as the dedication of participating families, underscoring the clinical program's success. ASCENIV, a key product in ADMA's portfolio of plasma-derived biologics, leverages the company's patented plasma donor screening and pooling methodology, enhancing its competitive positioning in the immune globulin market.