EPIC Study Overview
Johnson & Johnson announced the EPIC Phase 3b study to compare the efficacy of IMAAVY™ (nipocalimab-aahu) with efgartigimod in adults with generalized myasthenia gravis (gMG). This randomized, open-label study will assess disease control and safety, including a treatment-switch arm for participants transitioning from efgartigimod to IMAAVY™.
Study Objectives
The primary and secondary endpoints of the EPIC study include changes in total immunoglobulin G (IgG) levels and sustained disease control, measured by MG-ADL and QMG scores, 8-12 weeks post-treatment initiation.
Vibrance-MG Phase 2/3 LTE Data
New data from the Vibrance-MG Phase 2/3 long-term extension (LTE) study shows that IMAAVY™, combined with standard care, leads to sustained IgG reductions and disease control in pediatric patients aged 12 and older with gMG. The study reported a median IgG reduction of approximately 73% by Week 24, with improvements in daily function and muscle strength observed through 72 weeks.
Regulatory Approvals
IMAAVY™ has received approval for treating gMG in adults and pediatric patients aged 12 and older in the U.S., Brazil, and Japan. The approvals cover patients with anti-AChR, anti-MuSK, or anti-LRP4 antibody-positive gMG, depending on the region.
