Argenx announced that The Lancet Neurology has published pivotal trial results from the Phase 3 ADAPT trial of efgartigimod for the treatment of adults living with generalized myasthenia gravis (gMG). Results from ADAPT showed treatment with efgartigimod led to clinically meaningful improvements in strength and quality of life measures. Efgartigimod is currently under review with the U.S. FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of December 17, 2021.
ADAPT was a randomized, double-blind, placebo-controlled, multi-center, global trial enrolling 167 adult patients with gMG in North America, Europe and Japan. Patients were eligible to enroll in ADAPT regardless of antibody status, including patients with AChR antibodies (AChR-Ab+) and patients where AChR antibodies were not detected. Patients were randomized in a 1:1 ratio to receive efgartigimod or placebo for a total of 26 weeks. ADAPT was designed to enable an individualized treatment approach with an initial treatment cycle followed by a variable number of subsequent treatment cycles.
The ADAPT trial met its primary endpoint demonstrating significantly more acetylcholin...
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