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.