Argenx moves toward FDA submission with Vyvgart after Phase 3 success in autoimmune myositis indication

Argenx has submitted Vyvgart to the FDA following positive Phase 3 trial results for autoimmune myositis, specifically targeting immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM).

The Phase 3 Alkivia study in autoimmune myositis showed patients treated with Vyvgart Hytrulo achieved a 15.4-point greater improvement on a clinical efficacy measure at 52 weeks versus placebo, with strong efficacy in the underserved IMNM subgroup.

Vyvgart has already received FDA approval for generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP), and the company plans to move quickly on regulatory submissions based on the new data.

The IMNM program has received Breakthrough Therapy designation from the FDA, underscoring its potential as a major new market for Vyvgart beyond its core neurology indications.