FDA Approves Efgartigimod Alfa-fcab for Generalized Myasthenia Gravis
The approval of Vyvgart is the first for a therapy designed to reduce pathogenic IgGs, an underlying driver of gMG.
The FDA has approved efgartigimod alfa-fcab (Vyvgart, argenx SE) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
This makes efgartigimod alfa-fcab the first-and-only FDA-approved neonatal Fc receptor (FcRn) blocker.
“Today is the start of a new era for argenx and the gMG community as we honor our commitment to bring forward an innovative treatment option for people living with this debilitating disease. The approval of Vyvgart represents many achievements: our first approved product; the first-and-only FDA-approved neonatal Fc receptor blocker; and the first approved therapy designed to reduce pathogenic IgGs, an underlying driver of gMG,” Tim Van Hauwermeiren, CEO of argenx, said in a statement.
According to the statement, gMG is a rare, chronic neuromuscular disease characterized by debilitating and potentially life-threatening muscle weakness. The approval was based on results from the global phase 3 ADAPT trial, which met its primary endpoint and demonstrated that significantly more anti-AChR antibody positive gMG patients were responders on the MG-ADL scale following treatment with efgartigimod alfa-fcab compared with those on who took the placebo.
Efgartigimod alfa-fcab had a safety profile in the ADAPT clinical trial, and the most common adverse events were headaches, and respiratory and urinary tract infections, according to the study authors.
Argenx announces U.S. Food and Drug Administration (FDA) approval of VYVGART™ (efgartigimod alfa-fcab) in generalized myasthenia gravis. BusinessWire. News release. December 17, 2021. Accessed December 20, 2021. https://www.businesswire.com/news/home/20211217005641/en