Brand Name
Rystiggo
Generic Name
Rozanolixizumab
View Brand Information FDA approval date: June 26, 2023
Classification: Neonatal Fc Receptor Blocker
Form: Injection
What is Rystiggo (Rozanolixizumab)?
RYSTIGGO is indicated for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive. RYSTIGGO is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive.
Approved To Treat
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Brand Information
RYSTIGGO (ROZANOLIXIZUMAB)
1INDICATIONS AND USAGE
RYSTIGGO is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
2DOSAGE FORMS AND STRENGTHS
RYSTIGGO is a clear to slightly opalescent, colorless to pale brownish yellow solution available as:
- 280 mg/2 mL (140 mg/mL) in a single-dose vial.
- 420 mg/3 mL (140 mg/mL) in a single-dose vial.
- 560 mg/4 mL (140 mg/mL) in a single-dose vial.
- 840 mg/6 mL (140 mg/mL) in a single-dose vial.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
- Infections
- Aseptic Meningitis
- Hypersensitivity Reactions
4.1Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical studies, the safety of RYSTIGGO has been evaluated in 196 patients who received at least one dose of RYSTIGGO, including 88 patients exposed to at least 5 treatment cycles and 9 patients exposed to at least 10 treatment cycles.
In a placebo-controlled study (Study 1) in patients with gMG, 133 patients received RYSTIGGO
Patients treated with RYSTIGGO received 1 treatment cycle in Study 1. In an extension study, the minimum time for initiating subsequent treatment cycles, specified by study protocol, was 63 days from the start of the previous treatment cycle. Patients treated with RYSTIGGO on average initiated 4 cycles in one year (range 1 to 7 cycles). The median time between start of treatment cycles was 98 days for patients treated with RYSTIGGO who initiated 4 cycles.
Adverse reactions reported in at least 5% of patients treated with RYSTIGGO and more frequently than placebo are summarized in Table 2. The most common adverse reactions (reported in at least 10% of patients treated with RYSTIGGO) were headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.
5DESCRIPTION
Rozanolixizumab-noli, a neonatal Fc receptor blocker, is a recombinant, humanized IgG4P monoclonal antibody, expressed in a genetically engineered Chinese hamster ovary DG44 cell line. Rozanolixizumab-noli has an approximate molecular weight of 148 kDa.
6CLINICAL STUDIES
The efficacy of RYSTIGGO for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-AChR antibody positive or anti-MuSK antibody positive was established in a multicenter, randomized, double-blind, placebo-controlled study (Study 1; NCT03971422). The study included a 4-week screening period and a 6-week treatment period followed by 8 weeks of observation. During the treatment period, RYSTIGGO or placebo were administered subcutaneously once a week for six weeks.
Study 1 enrolled patients who met the following criteria:
- Presence of autoantibodies against AChR or MuSK
- Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IVa
- Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score of at least 3 (with at least 3 points from non-ocular symptoms)
- On stable dose of MG therapy prior to screening that included acetylcholinesterase (AChE) inhibitors, steroids, or non-steroidal immunosuppressive therapies (NSISTs), either in combination or alone
- Serum IgG levels of at least 5.5 g/L
In Study 1, a total of 200 patients were randomized 1:1:1 to receive weight-tiered doses of RYSTIGGO (n=133), equivalent to ≈7 mg/kg (n=66) or ≈10 mg/kg (n=67), or placebo (n=67). Baseline characteristics were similar between treatment groups. Patients had a median age of 52 years at baseline (range: 18 to 89 years) and a median time since diagnosis of 6 years. Sixty-one percent of patients were female, 68% were White, 11% were Asian, 3% were Black or African American, 1% were American Indian or Alaska Native, and 7% were of Hispanic or Latino ethnicity. Median MG-ADL total score was 8, and the median Quantitative Myasthenia Gravis (QMG) total score was 15. The majority of patients, 89.5% (n=179) were positive for AChR antibodies and 10.5% (n=21) were positive for MuSK antibodies.
At baseline in each group, over 83% of patients received AChE inhibitors, over 56% of patients received steroids, and approximately 50% received NSISTs, at stable doses.
Patients were treated with RYSTIGGO via subcutaneous infusion once per week for a period of 6 weeks
The efficacy of RYSTIGGO was measured using the MG-ADL scale, which assesses the impact of gMG on daily functions of 8 signs or symptoms that are typically affected in gMG. Each item is assessed on a 4-point scale where a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function. A total score ranges from 0 to 24, with the higher scores indicating more impairment.
The primary efficacy endpoint was the comparison of the change from baseline between treatment groups in the MG-ADL total score at day 43. A statistically significant difference favoring RYSTIGGO was observed in the MG-ADL total score change from baseline [-3.4 points in RYSTIGGO-treated group at either dose vs -0.8 points in the placebo-treated group (p<0.001)].
The secondary endpoint was the change between treatment groups from baseline to day 43 in the QMG. The QMG is a 13-item categorical grading system that assesses muscle weakness. Each item is assessed on a 4-point scale where a score of 0 represents no weakness and a score of 3 represents severe weakness. A total possible score ranges from 0 to 39, where higher scores indicate more severe impairment.
A statistically significant difference favoring RYSTIGGO was observed in the QMG total score change from baseline [-5.4 points and -6.7 points in RYSTIGGO-treated group at ≈7 mg/kg and ≈10 mg/kg dose level, respectively, vs -1.9 points in the placebo-treated group (p<0.001)].
The results are presented in Table 3.
Figure 1 shows the mean change from baseline in MG-ADL score at Day 43 in Study 1.
7PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton
NDC 50474-980-79
RYSTIGGO
280 mg/2 mL
For Subcutaneous Use Only
One single-dose vial - Discard unused portion.
To be administered by a healthcare provider only.
Recommended Dosage: See prescribing information.
OPEN HERE
8PRINCIPAL DISPLAY PANEL - 3 mL Vial Carton
NDC 50474-981-83
RYSTIGGO
420 mg/3 mL
For Subcutaneous Use Only
One single-dose vial - Discard unused portion.
To be administered by a healthcare provider only.
Recommended Dosage: See prescribing information.
OPEN HERE
9PRINCIPAL DISPLAY PANEL - 4 mL Vial Carton
NDC 50474-982-84
RYSTIGGO
560 mg/4 mL
For Subcutaneous Use Only
One single-dose vial - Discard unused portion.
To be administered by a healthcare provider only.
Recommended Dosage: See prescribing information.
OPEN HERE
10PRINCIPAL DISPLAY PANEL - 6 mL Vial Carton
NDC 50474-983-86
RYSTIGGO
840 mg/6 mL
For Subcutaneous Use Only
One single-dose vial - Discard unused portion.
To be administered by a healthcare provider only.
Recommended Dosage: See prescribing information.
OPEN HERE
