USFDAMay 4, 2026, 07:12 AM
ADMA Biologics' ASCENIV Approved for Pediatric Patients 2+ Years
AI Summary
ADMA Biologics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental Biologics License Application for ASCENIV™. This approval expands the drug's label to include pediatric immune compromised patients two years of age and older, a significant change from the previous restriction to patients aged 12 years and older. This allows ADMA to actively address the treatment needs of a younger patient population with primary humoral immunodeficiency.
Key Highlights
- FDA approved ADMA Biologics' supplemental Biologics License Application for ASCENIV™ label expansion.
- The approval expands ASCENIV's indication to include pediatric immune compromised patients two years of age and older.
- Previously, ASCENIV was restricted to primary humoral immunodeficiency (PI) patients aged 12 years and older.
- The approval fulfills the final study report for the Pediatric assessment post-marketing commitment.
- ASCENIV is a plasma-derived, polyclonal, intravenous immune globulin (IVIG) approved in April 2019.
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