By Fineline Cube 
Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission has granted Marketing Authorisation for IMAAVY (nipocalimab), a fully human FcRn‑blocking monoclonal antibody, as an add‑on to standard therapy for generalised myasthenia gravis (gMG).
Regulatory Approval & Patient Population
| Detail | Information |
|---|---|
| Product | IMAAVY (nipocalimab) |
| Approval | EU Marketing Authorisation |
| Indication | Add‑on therapy for gMG |
| Patient Population | Adults and adolescents ≥12 years, AChR or MuSK antibody‑positive |
| Market Coverage | ≥90% of antibody‑positive gMG population |
Clinical Evidence from Vivacity-MG3
- Study Design: Pivotal Phase 3, 24‑week randomized controlled trial
- Treatment Arms: Nipocalimab + standard of care (SOC) vs placebo + SOC
- Primary Endpoint: Superior disease control throughout 24 weeks
- Result: Nipocalimab arm demonstrated statistically significant superiority
- Mechanism: FcRn blockade reduces pathogenic IgG autoantibodies
Strategic Market Context
- gMG Prevalence: ~200,000 patients across EU; high unmet need for targeted therapies
- Competitive Edge: First FcRn blocker approved in EU for broad gMG population including MuSK‑positive patients
- Launch Timeline: J&J expects commercial rollout across EU member states in Q1 2026
- Financial Outlook: Analysts project peak EU sales of €800 million annually
Forward‑Looking Statements
This brief contains forward‑looking statements regarding commercial launch plans and market projections. Actual results may differ due to regulatory, competitive, and reimbursement risks.-Fineline Info & Tech