Brand Name
Imaavy
Generic Name
Nipocalimab
View Brand Information FDA approval date: April 29, 2025
Form: Injection
What is Imaavy (Nipocalimab)?
IMAAVY is indicated for the treatment of generalized myasthenia gravis in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive. IMAAVY is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive.
Approved To Treat
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Brand Information
IMAAVY (nipocalimab)
1INDICATIONS AND USAGE
IMAAVY is indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
2DOSAGE FORMS AND STRENGTHS
Injection: colorless to slightly brownish, clear to slightly opalescent solution available as:
- 300 mg/1.62 mL (185 mg/mL) in a single-dose vial
- 1,200 mg/6.5 mL (185 mg/mL) in a single-dose vial
3CONTRAINDICATIONS
IMAAVY is contraindicated in patients with a history of serious hypersensitivity reaction to nipocalimab or any of the excipients in IMAAVY. Reactions have included anaphylaxis and angioedema
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling
- Infections
- Hypersensitivity Reactions
- Infusion-related Reactions
4.1Clinical Trials 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.
5DESCRIPTION
Nipocalimab-aahu, a neonatal Fc receptor blocker, is a recombinant human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody, expressed in a genetically engineered Chinese hamster ovary cell line. Nipocalimab-aahu has an aglycosylated Fc region, therefore it lacks effector functions. Nipocalimab-aahu has an approximate molecular weight of 142 kilodaltons (kDa).
IMAAVY™ (nipocalimab-aahu) injection is a sterile, preservative-free, colorless to slightly brownish, clear to slightly opalescent solution, supplied in a single-dose vial for intravenous infusion after dilution.
Each single-dose vial contains either 300 mg/1.62 mL or 1,200 mg/6.5 mL of nipocalimab-aahu at a concentration of 185 mg/mL. In addition, each mL of solution contains arginine hydrochloride (25.35 mg), histidine (0.77 mg), L-histidine monohydrochloride monohydrate (1.07 mg), methionine (1.0 mg), polysorbate 80 (0.60 mg), sucrose (64.3 mg), and water for injection, USP, at a pH of 6.0.
6CLINICAL STUDIES
The efficacy of IMAAVY for the treatment of gMG in adults who are anti-AChR or anti-MuSK antibody positive was established in a 24-week, multicenter, randomized, double-blind, placebo-controlled study (Study 1; NCT04951622). Patients were treated with IMAAVY with the recommended dosage regimen
Study 1 enrolled patients with gMG who met the following criteria:
- Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IV
- Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score of at least 6
- On stable dose of standard of care MG therapy prior to baseline that included acetylcholinesterase (AChE) inhibitors, steroids or non-steroidal immunosuppressive therapies (NSISTs), either in combination or alone.
In Study 1, a total of 196 patients were randomized 1:1 to receive IMAAVY (n=98) or placebo (n=98). Baseline characteristics were similar between treatment groups. For the primary efficacy analysis population (n=153), patients had a median age of 52 years at screening (range 20 to 81 years) and a median time since diagnosis of 6 years. Sixty percent of patients were female; 63% were White; 32% were Asian; 1% were Black or African-American; and <1% were American Indian or Alaskan Native. At baseline, median MG-ADL total score was 9, and median Quantitative Myasthenia Gravis (QMG) total score was 15. Eighty-eight percent (n=134) of patients were positive for AChR antibodies and 10% (n=16) were positive for MuSK antibodies.
At baseline, in each group, 85% of patients received AChE inhibitors, 66% of patients received steroids, and 54% of patients received NSISTs at stable doses.
The efficacy of IMAAVY was measured using the MG-ADL scale, which assesses the impact of gMG on daily functions of 8 signs and 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 mean change from baseline to Weeks 22, 23, and 24 between treatment groups in the MG-ADL total score. A statistically significant difference favoring IMAAVY was observed in MG-ADL total score change from baseline (p=0.002; see
The efficacy of IMAAVY was also measured using the QMG total score, which is a 13-item categorial 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.
The secondary endpoint was the comparison of the mean change from baseline to Weeks 22 and 24 between treatment groups in the QMG total score. A statistically significant difference favoring IMAAVY was observed in the QMG total score change from baseline (p<0.001; see
The results are presented shown in Table 2.
Figure 1 shows the mean change from baseline to Week 24 in MG-ADL total score in Study 1, and Figure 2 shows the mean change from baseline to Week 24 in QMG total score in Study 1.
Figure 1: Least Squares Mean Change from Baseline in MG-ADL Total Score Over 24 Weeks in Study 1
LS = least squares, SE = standard error, MG-ADL = Myasthenia Gravis Activities of Daily Living
Figure 2: Least Squares Mean Change from Baseline in QMG Total Score Over 24 Weeks in Study 1
LS = least squares, SE = standard error, QMG = Quantitative Myasthenia Gravis.
7PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information).
8PRINCIPAL DISPLAY PANEL - 300 mg / 1.62 mL Vial Box
NDC 57894-800-01
imaavy™
300 mg / 1.62 mL
For Intravenous Infusion
Rx only
Johnson
9PRINCIPAL DISPLAY PANEL - 1,200 mg / 6.5 mL Vial Box
NDC 57894-801-01
imaavy™
1,200 mg / 6.5 mL
For Intravenous Infusion
Rx only
Johnson
