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US-RZ-2500361
RYSTIGGO is the first FDA-approved targeted treatment for adults with either anti-AChR antibody-positive or anti-MuSK antibody-positive generalized myasthenia gravis (gMG)1
Rapid efficacy
in action
for a broad population of adults with gMG1,2*
In a clinical study, RYSTIGGO demonstrated statistically significant
improvements vs placebo in MG-ADL total score at Week 6 (-3.4 vs -0.8; P<0.001),
with improvements observed as early as Week 1.1
The clinical study included adults who were anti-AChR Ab+ and anti-MuSK Ab+, and who had MGFA Class II-IVa disease, an MG-ADL score of ≥3 (with ≥3 points from non-ocular symptoms), serum IgG levels ≥5.5 g/L, and who were on a stable dose of MG therapy prior to screening.1
RYSTIGGO is the first FDA-approved targeted treatment for adults with either anti-AChR antibody-positive or anti-MuSK antibody-positive generalized myasthenia gravis (gMG)1
In a clinical study, RYSTIGGO demonstrated statistically significant improvements vs placebo in MG-ADL total score at Week 6 (-3.4 vs -0.8; P<0.001), with improvements observed as early as Week 1.1
The clinical study included adults who were anti-AChR Ab+ and anti-MuSK Ab+, and who had MGFA Class II-IVa disease, an MG-ADL score of ≥3 (with ≥3 points from non-ocular symptoms), serum IgG levels ≥5.5 g/L, and who were on a stable dose of MG therapy prior to screening.1
First FDA-approved targeted treatment
for adults with anti-MuSK Ab+ gMG; commercially available for 2+ years1
Minimal Symptom Expression (MSE) was achieved
- MG-ADL score of 0 or 1 - in adults taking RYSTIGGO in the pivotal study (RYSTIGGO 7 mg/kg [n=66]: 25.8%, 10 mg/kg [n=67]: 28.4%, placebo [n=67]: 3.0%)2†
Flexible dosing with individualized treatment-free intervals
- 6 weekly subcutaneous infusions followed by a treatment-free interval determined by clinical evaluation1‡§
MSE was an exploratory endpoint not controlled for multiplicity. Therefore, data should be interpreted with caution and conclusions cannot be drawn.
The efficacy 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 study. In the study, 200 adults 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
Adults who reached MSE achieved an MG-ADL score of 0 or 1 at any time up to and including Week 6 (Day 43) of the pivotal study.2
RYSTIGGO is intended for subcutaneous administration using an infusion pump at a constant flow rate of up to 20 mL/hr.1
If a scheduled infusion is missed, RYSTIGGO may be administered up to 4 days after the scheduled time point. Thereafter, resume the original dosing schedule until the treatment cycle is completed.1
Watch the RYSTIGGO Mechanism of Action Video
Explore how RYSTIGGO binds to FcRn with high affinity, reducing IgG recycling and leading to degradation.1,3∥¶
The precise mechanism through which RYSTIGGO exerts therapeutic effects is unknown.
Based on in vitro data.3
Start Your Patients on RYSTIGGO
Learn how to enroll patients in ONWARD®, a personalized support program built to help patients through every step of their RYSTIGGO treatment journey.
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=myasthenia gravis; MG-ADL=Myasthenia Gravis Activities of Daily Living; MGFA=Myasthenia Gravis Foundation of America; MuSK=muscle-specific tyrosine kinase.
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
- 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
