Argenx Submits BLA To FDA For Subcutaneous Efgartigimod For Generalized Myasthenia Gravis Treatment

(RTTNews) - argenx SE (ARGX) said that it has submitted a Biologics License Application to the U.S. Food and Drug Administration for Subcutaneous efgartigimod (1000mg efgartigimod-PH20) for the treatment of generalized myasthenia gravis (gMG) in adult patients.

The submission was based on positive data from the Phase 3 ADAPT-SC trial demonstrating noninferiority of subcutaneous efgartigimod compared to intravenously administered VYVGART (efgartigimod alfa-fcab) based on total immunoglobulin G or IgG reduction at day 29.

Efgartigimod is an antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies by binding to the neonatal Fc receptor and blocking the IgG recycling process. Efgartigimod is being investigated in several autoimmune diseases known to be mediated by disease-causing IgG antibodies, including neuromuscular disorders, blood disorders, and skin blistering diseases, in both an intravenous and subcutaneous (SC) formulation.

Generalized myasthenia gravis (gMG) is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness.