ADMA Biologics Wins FDA Approval for ASCENIV, Expanding Use to Children 2+

ADMA Biologics received FDA approval to expand the label for its drug ASCENIV. The therapy treats primary humoral immunodeficiency (PI).

The approval expands the drug's use to children aged two and older. Previously, ASCENIV was restricted to patients aged 12 and older.

ASCENIV is a plasma-derived intravenous immune globulin (IVIG) therapy. It provides antibodies to protect immunocompromised patients from infection.

This regulatory milestone fulfills an FDA post-marketing requirement. It allows ADMA to market the therapy to a younger patient population earlier in their treatment journey.