Argenx Reports ALKIVIA Gains, Plans IMNM Filing by Year-End
The Phase 3 study met its combined-population endpoints, while argenx plans to seek FDA review for efgartigimod in IMNM by year-end.
Key takeaways
- ALKIVIA met its primary and key secondary endpoints in the combined IMNM and DM population.
- IMNM patients had a 14.8-point greater mean TIS improvement than placebo at Week 52.
- Argenx plans to submit an FDA application for efgartigimod in IMNM by the end of 2026.
Argenx said its Phase 3 ALKIVIA study met its primary and key secondary endpoints in patients with immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM). At Week 52, efgartigimod produced a 15.4-point greater improvement in mean Total Improvement Score than placebo in the combined group.
In the IMNM group, the improvement over placebo was 14.8 points, and the result was statistically significant. Argenx said patients receiving efgartigimod also showed greater muscle-strength gains and a larger reduction in creatine kinase, a marker of muscle injury.
The DM group showed a 14.5-point greater mean score improvement than placebo, but the difference was not statistically significant. Argenx also reported improvement in skin disease severity and disease activity in that group.
The company plans to submit an application to the U.S. Food and Drug Administration for efgartigimod in IMNM by the end of 2026. It said the drug was generally well tolerated, with a safety profile consistent with prior studies.
At Friday’s close, argenx shares traded at $927.21, up 3.63% from the previous close.
This article was produced with the help of AI technology. Based on reporting by the outlets listed above.
