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

  • Argenx SE (NASDAQ: 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 (NASDAQ: 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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