IMAAVY (nipocalimab-aahu) · Johnson & Johnson
IMAAVY (nipocalimab-aahu) is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG). The medication is approved for use in adult and pediatric patients 12 years of age and older. It is specifically intended for patients who are positive for anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies.
How IMAAVY Works
Nipocalimab-aahu is a human IgG1 monoclonal antibody that targets and binds to the neonatal Fc receptor (FcRn). By binding to this receptor, the drug functions as a blocker. This action results in the reduction of circulating immunoglobulin G (IgG) levels in the body.
Details
- Status
- Prescription
- First Approved
- 2025-04-29
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
IMAAVY Approval History
What IMAAVY Treats
1 indicationsIMAAVY is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Myasthenia Gravis
IMAAVY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Johnson & Johnson's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
IMAAVY FDA Label Details
Indications & Usage
FDA Label (PDF)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 kinase (MuSK) antibody positive. 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.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.