JNJ · News · 20260929N

Imaavy Label Expansion

JOHNSON & JOHNSON · 2026-09-29 · Importance 31 · Surprise 42

Johnson & Johnson reported new two-year Phase 2/3 long-term-extension data for IMAAVY (nipocalimab-aahu) in adolescents with anti-AChR-positive generalized myasthenia gravis. The findings showed sustained disease control, improved daily function and muscle strength, and reduced corticosteroid use through two years, with no new safety concerns reported. A separate retrospective adult survey found fluctuating symptom control was a leading reason for discontinuing prior advanced therapies, while most surveyed patients reported improvement after switching to IMAAVY. The data were scheduled for presentation across 15 abstracts at the 2026 MGFA Scientific Session and AANEM Annual Meeting.

Key facts

• New two-year findings from the Phase 2/3 long-term extension demonstrate sustained disease control through two years for IMAAVY (nipocalimab-aahu) in generalized myasthenia gravis (gMG). source
• The Phase 2/3 long-term extension showed improvement in daily function and muscle strength and reductions in corticosteroid use in anti-AChR+a adolescents treated with IMAAVY. source
• Data on IMAAVY will be presented across 15 novel abstracts at the MGFA Scientific Session and AANEM Annual Meeting. source
• A retrospective survey in adults identified fluctuating symptom control as a top driver for discontinuing prior advanced treatment, with most patient outcomes improving after transitioning to IMAAVY. source