Despite argenx Vyvdura approval, quest for definitive myasthenia gravis cure persists in Japan

Japan has recently approved Dutch immunology specialist argenx’ (Euronext: ARGX) Vyvdura (efgartigimod alfa and hyaluronidase-qvfc) subcutaneous (SC) injection 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).

While introducing a novel subcutaneous administration route, Vyvdura adds to Japan’s myasthenia gravis (MG) treatment options. However, differentiation from the existing therapies remains marginal, leaving an unmet need for a unique and specifically curative approach in MG treatment, says pharma analytics firm GlobalData.

With the latest approval, Japan has expanded its treatment armamentarium against MG with two argenx formulations: the intravenous (IV) Vyvgart (efgartigimod alfa), first sanctioned by the Ministry of Health, Labor and Welfare (MHLW) in January 2022, and the subcutaneous (SC) Vyvdura. This adds to the existing lineup of four IV disease-modifying therapies (DMTs) - AstraZeneca’s (LSE: AZN) Soliris (eculizumab), Ultomiris (ravulizumab LA), argenx’ Vyvgart, UCB’s (Euronext: UCB) Rystiggo (rozanolixizumab), and one SC therapy, UCB’s Zilbrysq (zilucoplan), in Japan