SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• Please refer to the local labeling for relevant information regarding IMAAVY and use in patients with renal impairment.

RELEVANT INCLUSION/EXCLUSION CRITERIA FROM CLINICAL TRIALS

VIVACITY-MG3 Study

Vu et al (2024)¹ conducted a phase 3, randomized, multicenter, double-blind, placebo (PBO)-controlled study to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of IMAAVY in adults with gMG.

• Patients with a history of severe and/or uncontrolled renal disorder or with clinically significant abnormalities in screening laboratory results that could interfere with study participation and/or jeopardize patient safety or the validity of study results were excluded from the trial.²

Vibrance-mg

Ramchandren et al (2022)^3,4 is evaluating the safety, efficacy, PK, and PD of IMAAVY in children and adolescents aged 2 to <18 years with gMG who have an insufficient response to ongoing, stable standard of care therapy in an ongoing, open-label, uncontrolled multicenter clinical trial.

• Patients with a history of severe and/or uncontrolled renal disorder or with clinically significant abnormalities in screening laboratory results that could interfere with study participation and/or jeopardize patient safety or the validity of study results will be excluded from the trial.³ 

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 08 November 2024.