argenx’s Vyvdura Injection Receives MHLW’s Approval for Generalized Myasthenia Gravis
Shots:
- The Japanese MHLW has granted approval to Vyvdura (efgartigimod alfa and hyaluronidase-qvfc) injection for SC use to treat generalized myasthenia gravis (gMG) patients having inadequate response to steroids or non-steroidal immunosuppressive therapies (ISTs)
- The approval was supported by the P-III (ADAPT-SC) trial, a bridging study to the P-III (ADAPT) trial of Vyvgart, investigating the noninferiority of PD effect of Vyvdura vs Vyvgart in adult patients (n=110), randomized 1:1, with gMG
- The study results revealed that Vyvdura reduced total immunoglobulin G (IgG) levels from baseline vs Vyvgart (IV) in adult gMG patients
Ref: argenx | Image: argenx
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Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.