Argenx Seeks FDA Nod For Its Flagship Neuromuscular Treatment Formulated For Subcutaneous Injection

  • Argenx SE ARGX has submitted an FDA marketing application for SC efgartigimod for adult patients with generalized myasthenia gravis (gMG).
  • SC efgartigimod is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme Therapeutics Inc's HALO ENHANZE drug delivery technology. 
  • ENHANZE facilitates the subcutaneous injection delivery of biologics that are typically administered via intravenous (IV) infusion.
  • Related: Argenx's Drug Scores European Approval For Muscular Fatigue Disorder.
  • The submission package includes data from the Phase 3 ADAPT-SC study evaluating the noninferiority of SC efgartigimod compared to intravenously administered Vyvgart.
  • ADAPT-SC met its primary endpoint of total IgG reduction from baseline at day 29, demonstrating noninferiority of SC efgartigimod to Vyvgart. 
  • Patients treated with SC efgartigimod achieved a mean total IgG reduction of 66.4% from baseline at day 29, compared to a 62.2% reduction with Vyvgart. 
  • Results were consistent across the overall population. 
  • Further, 69.1% of patients treated with SC efgartigimod showed improved quality of life scores. 
  • The safety profile for SC efgartigimod was consistent with the ADAPT study. 
  • Price Action: ARGX shares are trading 0.01% lower at $370.43 on the last check Wednesday.
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