The US FDA has accepted the BLA for priority review of efgartigimod (1000mg, SC) in adult patients with gMG. The US FDA’s decision is expected on March 20, 2023
The submission was based on the P-III (ADAPT-SC) study evaluating efgartigimod vs Vyvgart (10mg/kg, IV) in a ratio (1:1) in 110 patients across North America, EU & Japan. The trial met its 1EPs i.e., mean total IgG reduction from baseline @29 Day (66.4% vs 62.2%) & showed noninferiority of efgartigimod, 69.1% & 65.5% responded on MG-ADL & QMG score, minimal symptom expression (37%) after 1 treatment cycle
The safety profile was consistent with the (ADAPT) study & was well-tolerated. Following the completion of the (ADAPT-SC) study, 95% entered a 3yr. OLE (ADAPT-SC+) study for efgartigimod
Ref: argenx | Image: argenx
