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argenx announces publication of Phase 3 ADAPT trial results of efgartigimod for the treatment of generalized myasthenia gravis in The Lancet Neurology

is under U.S. Food and Drug Administration (FDA) review with December 17, 2021 Prescription Drug User Fee Act (PDUFA) target action date Breda, the Netherlands Jun. 16, 2021 argenx (Euronext & Nasdaq: ARGX), today announced that The Lancet Neurology has published pivotal trial results from the Phase 3 ADAPT trial of efgartigimod, an FcRn antagonist, for the treatment of adults living with generalized myasthenia gravis (gMG). Efgartigimod is currently under review with the U.S. Food and Drug Administration (FDA) for the treatment of gMG with a Prescription Drug User Fee Act (PDUFA) target action date of December 17, 2021, and if approved, would be the first-and-only approved FcRn antagonist.

Human IgG1 Antibody Shows Promise in Myasthenia Gravis

email article More patients with myasthenia gravis who were treated with the investigational agent efgartigimod achieved a sustained improvement in a scale of activities of daily living compared with patients who were given placebo, a researcher reported. Of patients with generalized myasthenia gravis and anti-acetylcholine receptor antibody (AChR-Ab) positivity in a phase III study, 67.7% receiving efgartigimod achieved at least a 2-point improvement in their Myasthenia Gravis-Activities of Daily Living (MG-ADL) score after the first cycle of treatment, compared with 29.7% of those receiving placebo ( P

Janssen Showcases Phase 2 Nipocalimab (M281) Data in Adults with Generalized Myasthenia Gravis (gMG) at the 2021 American Academy of Neurology Virtual Meeting

Janssen Showcases Phase 2 Nipocalimab (M281) Data in Adults with Generalized Myasthenia Gravis (gMG) at the 2021 American Academy of Neurology Virtual Meeting Full results from the Vivacity-MG study to be presented for the first time during an oral presentation News provided by Share this article Share this article TITUSVILLE, N.J., April 16, 2021 /PRNewswire/  The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the full results from the Phase 2 Vivacity-MG study of the investigational compound, nipocalimab (M281), in generalized myasthenia gravis (gMG)–a chronic, autoimmune neuromuscular disease. The data will be featured as part of an oral presentation at the American Academy of Neurology (AAN) Virtual Meeting taking place April 17-22, 2021.

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