argenx SE (ARGX) announced the Japan's Ministry of Health, Labour and Welfare approved VYVDURA injection for subcutaneous use for the treatment of adult patients with generalized myasthenia gravis, who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies. VYVGART is now approved in Japan for both intravenous and self-administered SC use. The company noted that the approval is based on positive results from the Phase 3 ADAPT-SC study.
Hermann Strenger, General Manager, argenx Japan, said: "Bringing VYVDURA to Japan means there are now two formulations available for gMG patients, including the possibility to self-inject at home, allowing patients and their healthcare providers to choose the best option to meet their treatment needs."
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