SAN DIEGO, CA — Halozyme Therapeutics, Inc., 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.
About Halozyme
Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. As the innovators of the ENHANZE® technology with the proprietary enzyme rHuPH20, Halozyme’s commercially-validated solution is used to facilitate the delivery of injected drugs and fluids in order to reduce the treatment burden to patients. Having touched more than 800,000 patient lives in post-marketing use in seven commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, AbbVie, Eli Lilly, Bristol Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals.
Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technology that are designed to provide commercial or functional advantages such as improved convenience and tolerability, and enhanced patient comfort and adherence. The Company has a commercial portfolio of proprietary products including Hylenex® and XYOSTED® and partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceuticals and Idorsia Pharmaceuticals.
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