Argenx's efgartigimod meets primary endpoint in Phase 3 autoimmune myositis trial
ARGX•argenx said its Phase 3 ALKIVIA trial met primary and key secondary endpoints in combined IMNM and dermatomyositis populations. It plans to submit an FDA application for IMNM by year-end 2026.
1. Trial results
The Phase 3 ALKIVIA trial met its primary and key secondary endpoints for efgartigimod in combined immune-mediated necrotizing myopathy (IMNM) and dermatomyositis populations. IMNM patients showed statistically significant, clinically meaningful improvement; dermatomyositis patients experienced clinically meaningful benefits that did not reach statistical significance in the smaller cohort.
2. Planned filing
argenx plans to submit a supplemental biologics license application to the FDA for IMNM by year-end 2026, supported by Breakthrough Therapy Designation. Results are scheduled to be presented at American College of Rheumatology Convergence on November 11, 2026.
