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Imaavy (NIPOCALIMAB)
Imaavy works by binding to and blocking the activity of certain immune cells that mistakenly attack healthy nerve-muscle connections in people with gMG.
Nipocalimab (Imaavy), marketed by Janssen Biotech, is a targeted therapy for Generalized Myasthenia Gravis (gMG) that binds to and blocks the activity of immune cells attacking healthy nerve-muscle connections. Its key strength lies in its mechanism of action, which addresses the root cause of gMG, potentially offering significant clinical benefits. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generic alternatives.
At a glance
| Generic name | NIPOCALIMAB |
|---|---|
| Sponsor | Janssen Biotech |
| Modality | Monoclonal antibody |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2025 |
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.
Approved indications
- Generalized Myasthenia Gravis (gMG)
Common side effects
- Respiratory tract infection
- Peripheral edema
- Muscle spasms
- Hypersensitivity reaction
- Infusion-related reaction
- Urinary tract infection
- Herpes
- Influenza
- Oral infection
- Skin infection
- COVID-19
- Pneumonia
Drug interactions
- medications that bind to the human neonatal Fc receptor (e.g., immunoglobulin products, monoclonal antibodies, or antibody derivates containing the human Fc domain of the IgG subclass)
Key clinical trials
- Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia (PHASE2,PHASE3)
- Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (PHASE2,PHASE3)
- A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis (PHASE2,PHASE3)
- A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus (PHASE3)
- A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies (PHASE2)
- A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) (PHASE3)
- A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN) (PHASE3)
- Nipocalimab in Moderate to Severe Sjogren's Disease (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Imaavy CI brief — competitive landscape report
- Imaavy updates RSS · CI watch RSS
- Janssen Biotech portfolio CI