Argenx SE ARGX ) has announced topline data from the Phase 3 ADAPT-SC study evaluating subcutaneous (SC) efgartigimod for generalized myasthenia gravis (gMG).
- Myasthenia gravis is a chronic autoimmune neuromuscular disease that causes weakness in the skeletal muscles.
- SC efgartigimod achieved the primary endpoint of total IgG reduction from baseline at day 29, demonstrating statistical noninferiority to Vyvgart (efgartigimod alfa-fcab) intravenous (IV) formulation.
- Argenx plans to submit a Biologics License Application (BLA) to the FDA by the end of 2022.
- SC efgartigimod is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme Therapeutics Inc's HALO ENHANZE drug delivery technology that facilitates subcutaneous injection delivery of biologics that are typically administered via infusion.
- Related: Argenx's Vyvgart Wins FDA Approval For Autoimmune, Neuromuscular Disease.
- SC efgartigimod demonstrated a mean total IgG reduction of 66.4% from baseline at day 29, compared to 62.2% with Vyvgart.
- Additional key secondary endpoints were met, consistent with clinical efficacy results seen in the Vyvgart Phase 3 ADAPT study,
- SC efgartigimod demonstrated a safety profile consistent with the Phase 3 ADAPT study. It was generally well-tolerated.
- Price Action: ARGX shares are up 3.92% at $310.21 during the market session on the last check Tuesday.
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