Halozyme Therapeutics, Inc. announced that argenx received approval from Japan'sMinistry of Health, Labour and Welfare (MHLW) for VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) injection co-formulated with Halozyme's ENHANZE® drug delivery technology for subcutaneous (SC) use for the treatment of adult patients with generalized myasthenia gravis (gMG), who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies. The approval of VYVDURA® is based on positive results from the Phase 3 ADAPT-SC study. ADAPT-SC established the efficacy of VYVDURA® by demonstrating a reduction in percent change from baseline in total immunoglobulin G (IgG) levels comparable to VYVGART® IV in adult gMG patients.

ADAPT-SC was a bridging study to the Phase 3 ADAPT study, which formed the basis for approval of VYVGART® in Japan in January 2022. VYVDURA® is the brand name in Japan for what is branded as VYVGART® Hytrulo in the United States.