Drug updated on 10/21/2024
| Dosage Form | Injection (subcutaneous; 280 mg/2 mL [140 mg/mL], 420 mg/3 mL [140 mg/mL], 560 mg/4 mL [140 mg/mL], 840 mg/6 mL [140 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 patients who are anti-acetylcholine receptor (AChR) or antimuscle-specific tyrosine kinase (MuSK) antibody positive
Latest News
Summary
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- The overall mean change in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score across all treatments was -2.17 points (95% Confidence Interval [CI] -2.67, -1.67; p < 0.001) compared to placebo, although specific data for rozanolixizumab's effect on the MG-ADL score is not provided separately.
- The overall mean change in Quantitative Myasthenia Gravis (QMG) score was -3.46 (95% CI -4.53, -2.39; p < 0.001), with FcRn treatments, including rozanolixizumab, showing a higher reduction in QMG score (-4.78) compared to complement inhibitors (-2.60; p < 0.001).
- Efgartigimod had the highest probability of being the best treatment in the network meta-analysis, followed by rozanolixizumab, indicating its relative effectiveness in managing myasthenia gravis.
- There is no safety information available in the reviewed documents.
- There is no population types or subgroups information available in the reviewed documents.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Rystiggo (rozanolixizumab-noli) Prescribing Information. | 2024 | UCB, Inc., Smyrna, GA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy of innovative therapies in myasthenia gravis: A systematic review, meta-analysis and network meta-analysis | 2023 | European Journal of Neurology |