The European Commission has issued a marketing authorization for Vivgart in addition to standard treatment for adults with pathologically tired skeletal muscles. He announces this in his press release. ArgenXa pharmaceutical manufacturer.
Efgartigimod (Vivgart) is the first drug in its class designed to reduce the number of pathogenic IgG antibodies in patients with generalized myasthenia gravis. The drug binds to the Fc receptor, which interferes with the use of IgG antibodies. Accumulating, they cause autoimmune damage to nerves and muscles.
The European Commission approved the drug based on the results of the Phase 3 ADAPT study, a 26-week, randomized, double-blind, placebo-controlled, multicenter study. It included 167 adults with myasthenia gravis. Patients treated with efgartigimod experienced significantly greater symptom relief, increased strength, and improved quality of life compared to those treated with placebo. Previous studies have shown that the effectiveness of Wivgart is about 67%.
Around 700,000 people worldwide suffer from myasthenia gravis, a rare chronic autoimmune neuromuscular disease that causes debilitating, potentially life-threatening muscle weakness and significantly impairs quality of life.
For many years there was no specific treatment for myasthenia gravis, and patients had to be limited to standard medications for autoimmune diseases. Many patients did not respond adequately to treatment. Soliris, another medication for myasthenia gravis, costs approximately US$470,000 for one year. Vivgart will be much more affordable for many patients as it costs less than US$225,000. Vivgart is recognized by the US Food and Drug Administration (FDA) in 2021. has been approved.