SUMMARY  

• The company cannot recommend any practices, procedures, or usage of IMAAVY that deviate from the approved labeling.
• An 8-week subcutaneous (SC) substudy of the VIVACITY-MG3 clinical trial is being conducted to evaluate the use of SC IMAAVY for the treatment of adult patients with generalized myasthenia gravis (gMG).¹  

CLINICAL DATA

VIVACITY-MG3 SC Substudy

VIVACITY-MG3 is a 24-week, phase 3, randomized, multicenter, double-blind (DB), PBO-controlled clinical trial (NCT04951622) that evaluated the efficacy and safety of IMAAVY in adult patients with gMG.²  Patients who completed the DB phase were eligible to enter an open-label extension (OLE), where all patients received IMAAVY 15 mg/kg intravenous (IV) every 2 weeks (Q2W) in addition to standard of care (SOC) therapy.³    

In an ongoing 8-week substudy of the VIVACITY-MG3 OLE phase, SC IMAAVY is being evaluated for use in adult patients with gMG.¹ 

Study Design/Methods

• The SC substudy consists of 2 cohorts where patients will receive SC IMAAVY weekly until week 8:
  • SC Cohort 1: Will include patients from the OLE phase of the VIVACITY-MG3 trial who meet entry criteria listed below. 
    • Inclusion Criteria:  
      • Reasonable abdominal skin area for SC administration
      • Willing to maintain stable dose of corticosteroids and/or immunosuppressants during the initial 8 weeks of the substudy
    • Exclusion Criteria: 
      • Recently tapered concomitant gMG medication in the OLE phase
      • Actively deteriorating at SC day 1 visit such that they meet the criteria for clinical deterioration
  • SC Cohort 2: Will include patients with gMG who have not previously received treatment with IMAAVY. 
• Patients who complete the 8-week treatment period will be eligible to continue receiving SC IMAAVY in the long-term extension (LTE) phase.

Literature Search

• A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^®
• (and/or other resources, including internal/external databases) was conducted on
• 10 November 2025.