Halozyme Therapeutics, Inc. (NASDAQ: HALO) (“Halozyme”) today 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.