[Pubmed] Rozanolixizumab: A Review in AChR or MuSK Autoantibody-Positive Generalised Myasthenia Gravis

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CNS Drugs. 2026 Sep 30. doi: 10.1007/s40263-026-01335-3. Online ahead of print.

ABSTRACT

Rozanolixizumab (rozanolixizumab-noli; RYSTIGGO®), a humanised immunoglobulin G4P monoclonal antibody, is a subcutaneously administered neonatal Fc receptor (FcRn) inhibitor approved for the treatment of both acetylcholine receptor (AChR) and muscle-specific kinase (MuSK) autoantibody-positive (Ab+) generalised myasthenia gravis (gMG) in adults. The pivotal, randomised, placebo-controlled phase III MycarinG trial demonstrated that a 6-week cycle of once-weekly rozanolixizumab ≈ 7 mg/kg or ≈ 10 mg/kg resulted in statistically significant and clinically meaningful improvements across all myasthenia gravis-specific scales assessed at day 43 versus placebo. Treatment benefits were rapid, sustained and consistent across repeated symptom-driven rozanolixizumab cycles. In a randomised, open-label, phase III crossover trial, self-administered rozanolixizumab improved MG symptoms regardless of whether manual push or infusion pump method was used. Rozanolixizumab was generally well tolerated with an acceptable safety profile; the most common adverse events were headache, diarrhoea, pyrexia and nausea. Thus, rozanolixizumab is an efficacious and generally well tolerated therapy for adults with AChR or MuSK Ab+ gMG, representing a convenient and valuable additional treatment option for these patients.

PMID:42814271 | DOI:10.1007/s40263-026-01335-3


Source: https://pubmed.ncbi.nlm.nih.gov/4281427 ... 8&v=2.20.1