Argenx: SC Efgartigimod Meets Primary Endpoint In Phase 3 ADAPT-SC Trial In GMG - Quick Facts

(RTTNews) - Dutch immunology company argenx SE (ARGX) announced Tuesday positive topline data from the Phase 3 ADAPT-SC study evaluating subcutaneous (SC) efgartigimod (1000mg efgartigimod-PH20) for the treatment of generalized myasthenia gravis or gMG.

The company noted that SC efgartigimod achieved the primary endpoint of total IgG reduction from baseline at day 29, demonstrating statistical noninferiority to VYVGART (efgartigimod alfa-fcab) intravenous formulation in gMG patients.

Based on these results, argenx plans to submit a Biologics License Application or BLA to the U.S. Food and Drug Administration by the end of 2022.

SC efgartigimod is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE drug delivery technology.

Detailed data from the ADAPT-SC trial will be submitted for presentation at a future medical meeting.