Efgartigimod Alfa

argenx said Monday the subcutaneous (SC) version of its human IgG1 antibody fragment Vyvgart (efgartigimod alfa), marketed as Vyvgart Hytrulo, cleared a Phase III trial in adults with autoimmune myositis. "For decades, people living with autoimmune myositis have relied on corticosteroids and broad immunosuppression," said Luc Truyen, chief medical officer of argenx, noting that "precision targeting of FcRn with [Vyvgart] can deliver meaningful benefit in this disease." The late-stage portion of the Phase II/III ALKIVIA study enrolled 175 patients, who were randomised to receive either weekly Vyvgart Hytrulo or placebo for 52 weeks, with the primary endpoint being mean Total Improvement Score (TIS) at the end of treatment. Top-line results showed that in the combined immune-mediated necrotising myopathy (IMNM) and dermatomyositis (DM) cohort, patients treated with Vyvgart Hytrulo demonstrated a statistically significant 15.4-point gain in mean TIS over placebo recipients at week 52, with benefits emerging as early as week 4 and sustaining through the full year, even on steroid tapering. Additionally, subtype analyses highlighted a significant 14.8-point mean TIS improvement with Vyvgart Hytrulo over placebo in patients with IMNM, but a non-significant 14.5-point gain in those with DM. All six core TIS measures, covering muscle strength, physical function and extramuscular disease activity, favoured efgartigimod in both subtypes, with additional skin activity improvement noted in DM. The company said the SC FcRn inhibitor's safety profile was consistent with prior studies. Detailed findings from the study will be presented at an upcoming medical conference. Vyvgart was first cleared by the FDA as an intravenous infusion in 2021 for generalised myasthenia gravis (gMG), followed by the SC formulation, combining Vyvgart with hyaluronidase, in 2023. The latter was subsequently approved for chronic inflammatory demyelinating polyneuropathy in 2024. Meanwhile, the franchise is being investigated for other IgG-mediated autoimmune conditions such as Sjögren’s disease and systemic sclerosis, while also seeking a potential label expansion in ocular MG. The content above comes from the network. if any infringement, please contact us to modify.