BLAINJECTIONINJECTABLEPriority Review
Approved
Apr 2025
Lifecycle
Launch
Competitive Pressure
30/100
Data completeness
5/8 — Partial
Priority Review
IMAAVY (nipocalimab-aahu) by Johnson & Johnson is nipocalimab-aahu is a human igg1 monoclonal antibody that binds to neonatal fc receptor (fcrn), resulting in the reduction of circulating igg levels. Approved for generalized myasthenia gravis (gmg) in adult, older, anti-muscle-specific tyrosine kinase (musk) antibody positive and 3 more indications. First approved in 2025.
Drug data last refreshed 23h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IMAAVY (nipocalimab-aahu) is a human IgG1 monoclonal antibody that binds to the neonatal Fc receptor (FcRn), reducing circulating IgG levels. It is approved for generalized myasthenia gravis (gMG) in anti-MuSK antibody-positive adults and warm autoimmune hemolytic anemia (wAIHA) in previously corticosteroid-treated adults. This mechanism targets the underlying autoimmune pathology by clearing pathogenic antibodies.
Growth
IMAAVY launches into niche autoimmune indications with moderate competitive pressure (30%), suggesting focused commercial teams focused on specialist penetration in neurology and hematology.
Mechanism of Action
Nipocalimab-aahu is a human IgG1 monoclonal antibody that binds to neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG levels.
Indications (6)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.