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 hepatic impairment.

RELEVANT INCLUSION/EXCLUSION CRITERIA FROM CLINICAL TRIALS

VIVACITY-MG3 Study

Antozzi et al (2025)¹ conducted a phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of IMAAVY in adults with generalized myasthenia gravis (gMG).

• Patients with a history of severe and/or uncontrolled hepatic disorder (i.e., viral/alcoholic/autoimmune hepatitis/ cirrhosis and/or metabolic liver disease) 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 Study

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

• Patients with a history of severe and/or uncontrolled hepatic disorder (i.e., viral/alcoholic/autoimmune hepatitis/ cirrhosis and/or metabolic liver disease) or with clinically significant abnormalities in screening laboratory results that could interfere with study participation and/or might 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 16 October 2025.