The European Commission has granted marketing authorization for Vivgart as an addition to standard care for adults with disease characterized by persistently fatigued skeletal muscles. This announcement comes as authorities move to broaden treatment options for a rare autoimmune condition. ArgenXa, the biopharma behind this therapy, notes the milestone as a key step in expanding access for patients in Europe and beyond.
Efgartigimod, marketed as Vivgart, represents the first therapy in its class designed to reduce circulating pathogenic IgG antibodies in people with generalized myasthenia gravis. The medicine targets the Fc receptor, interrupting the recycling and use of IgG antibodies that, when present in excess, contribute to autoimmune nerve and muscle damage. By lowering these harmful antibodies, the approach aims to lessen symptoms and improve daily function for many patients.
The EU decision followed data from the Phase 3 ADAPT study, a 26‑week, randomized, double‑blind, placebo‑controlled, multicenter trial that enrolled 167 adults with myasthenia gravis. Participants receiving efgartigimod showed meaningfully greater relief from symptoms, improved muscle strength, and better quality of life compared with those given placebo. Earlier research has indicated a robust signal for Vivgart, with effectiveness estimates around two‑thirds of patients responding favorably in the studied setting.
Globally, myasthenia gravis affects roughly 700,000 people, a rare autoimmune neuromuscular disorder that can cause disabling, potentially life‑threatening muscle weakness and a substantial impact on daily living. The condition has long posed treatment challenges, with patients often relying on therapies aimed at broad immune suppression rather than targeted antibody reduction.
Historically, patients faced limited options and variable responses to standard therapies for autoimmune diseases. In some cases, existing treatments carried substantial cost burdens or insufficient efficacy. While Soliris has been used in certain myasthenia gravis cases, its annual cost has been reported near the upper end of six figures in USD terms. Vivgart is positioned as a potentially more accessible choice for many patients, with price expectations discussed in the context of broader U.S. and international pricing discussions. In the United States, Vivgart has received regulatory recognition from the Food and Drug Administration in 2021 and continues to be integrated into treatment landscapes where appropriate, complemented by ongoing payer and patient support programs. This broader availability aligns with ongoing efforts to improve affordability and access for people affected by this condition in North America and Europe. In Canada and the United States, clinicians are evaluating how Vivgart may fit alongside existing therapies, balancing efficacy, safety, and cost considerations to optimize patient outcomes.