Imaavy (nipocalimab-aahu)

BL 761430

Imaavy (nipocalimab-aahu)

BL 761430

U.S. License Holder:

Janssen Biotech

Date of License:

April-29-2025

Last Update:

August-31-2026

approved_indications FDA-Approved Indications

IMAAVY (nipocalimab-aahu) is a neonatal Fc receptor blocker indicated for the treatment of:

Generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive;

Warm autoimmune hemolytic anemia (wAIHA) in adult and pediatric patients 12 years of age and older currently or previously treated with corticosteroids.

Methodology

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