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FDA Medication Tracker

← All approvals · Brain & mental health · 2025

Imaavy (nipocalimab-aahu)

The FDA approved Imaavy (nipocalimab-aahu) on April 29, 2025 to treat generalized myasthenia gravis.
Brand name
Imaavy
Generic name
nipocalimab-aahu
FDA approval date
April 29, 2025
Approved use (FDA wording)
To treat generalized myasthenia gravis
Company
Janssen Biotech
Application
BLA761430
Dosage form / route
INJECTABLE · INJECTION
Boxed warning on label
Not listed
Category on this site
Brain & mental health

Indications and usage, from the FDA label

IMAAVY 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. ( 1.1 ) warm autoimmune hemolytic anemia (wAIHA) in adult and pediatric patients 12 years of age and older currently or previously treated with corticosteroids. ( 1.2 ) 1.1 Generalized Myasthenia Gravis (gMG) IMAAVY is 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 kina…

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.