Halozyme Therapeutics announced that argenx received approval from MHLW (Japan), for Vyvdura injection co-formulated with Halozyme’s ENHANZE drug delivery technology.- Halozyme + argenx.

The approval of Vyvdura is based on positive results from the Phase III ADAPT-SC study. ADAPT-SC established the efficacy of Vydura by demonstrating a reduction in percent change from baseline in total immunoglobulin G levels comparable to Vyvgart IV in adult gMG patients. ADAPT-SC was a bridging study to the Phase III 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 Halozyme Therapeutics announced that argenx received approval from Japan’s Ministry of Health, Labour and Welfare, or MHLW, for Vyvdura injection co-formulated with Halozyme’s ENHANZE drug delivery technology for subcutaneous, or SC, use for the treatment of adult patients with generalized myasthenia gravis, or 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 III ADAPT-SC study. ADAPT-SC established the efficacy of Vyvdura by demonstrating a reduction in percent change from baseline in total immunoglobulin G levels comparable to Vyvgart IV in adult gMG patients. ADAPT-SC was a bridging study to the Phase III 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 U.S.in the U.S.