RYSTIGGO is the first FDA-approved targeted treatment for adults with either anti-AChR Ab+ or anti-MuSK Ab+ generalized myasthenia gravis (gMG)1
POWERFUL
EFFICACY
IN
ACTION1
POWERFUL
Actor Portrayal.
Statistically significant reduction in MG-ADL total score at Week 6 in the pivotal study1*
-3.4
in both RYSTIGGO groups†
(P<0.001)
vs -0.8 (placebo)
Along with clinically meaningful (≥2.0-point) improvement at Week 61,2
The efficacy of RYSTIGGO was established in an up to 18-week, multicenter, randomized, double-blind, placebo-controlled study of 200 patients.1
RYSTIGGO 7 mg/kg (n=66), RYSTIGGO 10 mg/kg (n=67), placebo (n=67).1
Actor Portrayal.
RYSTIGGO is the first FDA-approved targeted treatment for adults with either anti-AChR Ab+ or anti-MuSK Ab+ generalized myasthenia gravis (gMG)1
FLEXIBLE DOSING
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ACTION1
FLEXIBLE
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RYSTIGGO provides cyclical dosing with a fixed 6‑week dosing cycle followed by a flexible, individualized break in treatment1,3‡
RYSTIGGO is administered once weekly in 6‑week dosing cycles followed by a treatment break determined by clinical evaluation.1
The safety of initiating subsequent cycles sooner than 9 weeks (6‑week treatment period and a 4-week follow-up period) from the start of the previous treatment cycle has not been established.1,3
Actor Portrayal.
Learn about the Mechanism of Action of RYSTIGGO
See how RYSTIGGO binds to FcRn with high affinity, reducing IgG recycling and leading to degradation.1,4‖¶
The precise mechanism through which RYSTIGGO exerts therapeutic effects is unknown.
Based on in vitro data.4
Watch a real-world video series about RYSTIGGO in action
Dr. Warren and her patient, William, have a candid conversation about their experience with RYSTIGGO.
First FDA-approved targeted treatment
for adults with anti-MuSK Ab+ gMG; commercially available for 3+ years1
Statistically significant QMG score reduction
An over 5-point reduction in both RYSTIGGO dose groups (7 mg/kg: -5.4, 10 mg/kg: -6.7; P<0.001) vs placebo (-1.9) at Week 61
Extension study
data
RYSTIGGO was further evaluated in adults over time in 2 extension studies5
The RYSTIGGO extension studies were open label and not placebo controlled; therefore, the efficacy and clinical significance of the results should be interpreted with caution.
The efficacy and safety of RYSTIGGO for the treatment of adults with anti-AChR Ab+ and anti-MuSK Ab+ gMG was established in an up to 18-week, multicenter, randomized, double-blind, placebo-controlled Phase 3 study. In the study, 200 adults with gMG at least 18 years of age were randomized 1:1:1 to receive weight-tiered doses of RYSTIGGO (n=133), either 7 mg/kg (n=66) or 10 mg/kg (n=67) of RYSTIGGO, or placebo (n=67).1
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Access coding and billing support materials
Download a helpful reference guide with important codes, including J-Code J9333, sample claim forms, and coding and billing information for RYSTIGGO.
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Ab+=antibody positive; AChR=acetylcholine receptor; FcRn=neonatal Fc receptor; IgG=immunoglobulin G; MG-ADL=Myasthenia Gravis Activities of Daily Living; MuSK=muscle-specific tyrosine kinase; QMG=Quantitative Myasthenia Gravis.
References:
- RYSTIGGO [Prescribing Information]. Smyrna, GA: UCB, Inc.
- Bril V, Drużdż A, Grosskreutz J, et al. Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study. Lancet Neurol. 2023;22(5):383-394. doi:10.1016/S1474-4422(23)00077-7
- UCB, Inc. RYSTIGGO [BLA 761286]. U.S. Food and Drug Administration. Updated May 25, 2022. Accessed March 25, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761286Orig1s000IntegratedR.pdf
- Smith B, Kiessling A, Lledo-Garcia R, et al. Generation and characterization of a high affinity anti-human FcRn antibody, rozanolixizumab, and the effects of different molecular formats on the reduction of plasma IgG concentration. MAbs. 2018;10(7):1111-1130. doi:10.1080/19420862.2018.1505464
- Bril V, Drużdż A, Grosskreutz J, et al. Rozanolixizumab in generalized myasthenia gravis: pooled analysis of the phase 3 MycarinG study and two open-label extensions. J Neuromuscul Dis. 2025;12(2):218-230. doi:10.1177/22143602241305511
