BLAINJECTIONINJECTABLEPriority Review
Approved
Apr 2025
Lifecycle
Launch
Competitive Pressure
30/100
Data completeness
4/8 — 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. First approved in 2025.
Drug data last refreshed 2h ago · AI intelligence enriched 6d 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) to reduce circulating IgG levels. It is indicated for generalized myasthenia gravis (gMG) in adults, particularly those who are anti-MuSK antibody positive. This novel mechanism addresses a previously underserved patient population in autoimmune neuromuscular disease.
Launch
Early-stage launch in Q2 2025 with moderate competitive pressure (30/100); team expansion expected as market awareness and patient identification ramp.
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 (3)
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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.