The Ministry of Health, Labour and Welfare in Japan has approved Argenx’s VYVDURA (efgartigimod alfa and hyaluronidase-qvfc) injection for subcutaneous (SC) administration to treat generalised myasthenia gravis (gMG) in adults.
The approval is specifically for patients who have inadequate response to treatment with steroids or non-steroidal immunosuppressive therapies.
VYVDURA is co-formulated using the ENHANZE drug delivery technology of Halozyme.
The treatment is now indicated for both intravenous and subcutaneous use in the region.
The approval is based on the positive outcomes of the Phase III ADAPT-SC clinical trial.
The randomised, multicentre, open-label, parallel-group trial was designed to demonstrate the noninferiority of the pharmacodynamic (PD) effect of VYVDURA versus VYVGART in adult gMG patients.
It assessed the PD effect by comparing the percentage change from baseline for both total immunoglobulin G (IgG) and acetylcholine receptor (AChR) autoantibody levels at day 29.
The study also evaluated the clinical efficacy, safety, immunogenicity and pharmacokinetics of the therapy.
Patients were randomised into a 1:1 ratio to receive VYVDURA or VYVGART for a treatment cycle comprising four doses once a week.
The trial enrolled 110 adult subjects from Europe, North America and Japan.
VYVDURA demonstrated efficacy in lowering total IgG levels comparable to that of VYVGART IV.
ADAPT-SC served as a bridging study to the Phase III ADAPT trial, which was the foundation for the initial approval of VYVGART in Japan in January 2022.
Patients in Japan now have the option of a self-administered SC treatment for gMG.
argenx Japan general manager Hermann Strenger stated: “The 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.
“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.”
