FDA Expands ASCENIV Pediatric Use - Summary - MDSpire
FDA & Government News

FDA Expands ASCENIV Pediatric Use

Label change follows completion of required pediatric evaluation and updates prior age restrictions for treatment eligibility.

  • By

  • Kathryn Wighton

  • May 4, 2026

  • 2 min

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The FDA has expanded the approval of ASCENIV, an intravenous immune globulin, to include pediatric patients aged 2 years and older with primary humoral immunodeficiency. Initially approved for patients 12 years and older, this shift reflects a significant step in addressing the needs of younger patients. Manufactured by ADMA Biologics, ASCENIV utilizes an innovative plasma donor screening method and exhibits potential risks such as thrombosis and renal dysfunction, necessitating careful patient monitoring for adverse effects.

Original Source(s)

FDA Expands ASCENIV Pediatric Use

  • by Kathryn Wighton

  • May 4, 2026

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