RYSTIGGO is the first and only 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 immunoglobulin G levels ≥5.5 gL, and who were on a stable dose of MG therapy prior to screening.1
RYSTIGGO is the first and only 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 immunoglobulin G levels ≥5.5 gL, and who were on a stable dose of MG therapy prior to screening.1
First and only
targeted treatment
FDA-approved for adult patients with anti-MuSK Ab+ gMG1
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): 26%, 10 mg/kg (n=67): 28%, placebo (n=67): 3%]2†
Once-weekly subcutaneous infusions
delivered in a 6-week treatment cycle by a healthcare professional1
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 adult patients were randomized 1:1:1 to receive weight-tiered doses of RYSTIGGO (n=133), either 7 mg/kg of RYSTIGGO (n=66) or 10 mg/kg (n=67), or placebo (n=67).1
†Patients 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
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
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Ab+=antibody positive; AChR=acetylcholine receptor; FcRn=neonatal Fc receptor; gMG=generalized myasthenia gravis; IgG=immunoglobulin G; 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
