Pharma Focus Asia

Halozyme Announces That Argenx Has Obtained Approval in Japan for VYVDURA® (Efgartigimod Alfa and Hyaluronidase-qvfc) Co-formulated With ENHANZE®

Friday, January 19, 2024

Halozyme Therapeutics, Inc. (NASDAQ: HALO) has announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted approval for VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) injection, co-formulated with Halozyme's ENHANZE® drug delivery technology for subcutaneous (SC) use. This approval is for treating adult patients with generalized myasthenia gravis (gMG) who do not respond adequately to steroids or non-steroidal immunosuppressive therapies.

Dr. Helen Torley, President and Chief Executive Officer of Halozyme, expressed satisfaction with argenx's global expansion of ENHANZE-enabled subcutaneous VYVGART into Japan. The approval allows patients the option of self-administering SC VYVGART with ENHANZE at home, providing an additional treatment choice.

The approval of VYVDURA® is based on positive results from the Phase 3 ADAPT-SC study, demonstrating its efficacy by showing a reduction in the percent change from baseline in total immunoglobulin G (IgG) levels, comparable to VYVGART® IV in adult gMG patients. ADAPT-SC served as a bridging study to the Phase 3 ADAPT study, instrumental in obtaining approval for VYVGART® in Japan in January 2022.

In Japan, VYVDURA® is the brand name for the product known as VYVGART® Hytrulo in the United States.



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