Halozyme Announces argenx Received Approval in Japan for VYVDURA (efgartigimod alfa and hyaluronidase-qvfc) Co-Formulated with ENHANZE for Generalized Myasthenia Gravis

Halozyme Therapeutics, Inc. announced that argenx received approval from Japan’s Ministry 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.

“We are pleased that argenx continues to expand its global reach of ENHANZE-enabled subcutaneous VYVGART to Japan,” said Dr. Helen Torley, president and chief executive officer of Halozyme. “Today’s approval includes the opportunity for patient self-administration of SC VYVGART with ENHANZE at home, adding an additional treatment option for patients.”

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.