ARGX - argenx Announces Approval of VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) Injection for Subcutaneous Use in Japan for Generalized Myasthenia Gravis | Benzinga
- Availability of VYVGART® and self-administered VYVDURA demonstrates continued commitment to providing more choice and flexibility for gMG patients in Japan
Jan. 18, 2024, 7:00 AM CET
Amsterdam, the Netherlands – argenx SE ((Euronext &, NASDAQ:ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) approved VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) injection 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 (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. "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."
The approval of VYVDURA is based on positive results from the Phase 3 ...