Argenx : FDA Accepts BLA For SC Efgartigimod In Generalized Myasthenia Gravis With Priority Review

argenx SE (ARGX) said that the U.S. Food and Drug Administration has accepted for priority review a Biologics License Application (BLA) for Subcutaneous efgartigimod (1000mg efgartigimod-PH20) for the treatment of adult patients with generalized myasthenia gravis.

The application has been granted a Prescription Drug User Fee Act (PDUFA) target action date of March 20, 2023.

The submission was based on positive results from the Phase 3 bridging study demonstrating noninferior total IgG reduction at day 29 with subcutaneously (SC) administered efgartigimod compared to intravenous (IV) administration.

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.

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