Drug updated on 5/14/2025
| Dosage Form | Injection (intravenous: 300 mg/1.62 mL [185 mg/mL], 1,200 mg/6.5 mL [185 mg/mL]) |
| Drug Class | Neonatal Fc receptor blockers |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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
Latest News
Summary
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- In patients with myasthenia gravis, neonatal Fc receptor (FcRn) inhibitors significantly reduced Myasthenia Gravis Activities of Daily Living (MG-ADL) scores compared to placebo (mean difference (MD) = -1.45 \[95% confidence interval (CI), -1.91 to -0.99]; P < 0.00001), with rozanolixzumab demonstrating superior efficacy over nipocalimab (MD range, 2 to 3.69; highest surface under the cumulative ranking curve (SUCRA) value 83%).
- Quantitative Myasthenia Gravis (QMG) scores were significantly reduced by FcRn inhibitors compared to placebo (MD = -2.33 \[95% CI, -3.57 to -1.09]; P = 0.0002), though nipocalimab had the least effect (standardized mean difference (SMD) = -0.02; 95% credible interval (CrI), -1.04 to 1.00), while batoclimab ranked highest in SUCRA value for QMG score reduction.
- Myasthenia Gravis Composite (MGC) and 15-item Myasthenia Gravis Quality of Life revised (MGQoL15r) scores were significantly improved with FcRn inhibitors compared to placebo (MGC: MD = -2.96 \[95% CI, -4.29 to -1.63]; P < 0.0001; MGQoL15r: MD = -2.18 \[95% CI, -3.35 to -1.00]; P = 0.0003), with nipocalimab being less effective than rozanolixzumab in improving MGC scores.
- Serious adverse events were lower with FcRn inhibitors (32/519) compared to placebo (39/397); batoclimab significantly reduced adverse-event incidence versus placebo (risk ratio (RR), 0.19; 95% CrI, 0 to 0.97), while nipocalimab and other drugs showed no statistically significant differences.
- Rozanolixzumab was associated with more adverse events compared to nipocalimab and other FcRn inhibitors; belimumab had the highest SUCRA value for safety, showing significant difference versus rozanolixzumab (RR 0.08, 95% CrI 0.01 to 0.94).
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Imaavy (nipocalimab-aahu) Prescribing Information | 2025 | Janssen Biotech, Inc., Horsham, PA |