argenx gains Japanese approval for Vyvdura in gMG

Dutch immunology specialist argenx (Euronext: ARGX) has announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) approved Vyvdura (efgartigimod alfa and hyaluronidase-qvfc; also marketed under the Vyvgart brand name) injection subcutaneous (SC).

The drug is authorized for the treatment of adult patients with generalized myasthenia gravis (gMG), who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs). Following this decision, Vyvgart is now approved in Japan for both intravenous (IV) and self-administered SC use.

“Today’s approval of Vyvdura marks a significant milestone for the gMG community in Japan and furthers our commitment to deliver innovative treatments to autoimmune patients globally,” said Hermann Strenger, general manager, argenx Japan, adding: “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.”