argenx Reports the BLA Submission to the US FDA for Efgartigimod to Treat Generalized Myasthenia Gravis
Shots:
- The submission was based on the P-III (ADAPT-SC) study evaluating the noninferiority of the PD effect of efgartigimod (1000mg, SC) vs Vyvgart (IV, 10mg/kg) in a ratio (1:1) in 110 adult patients with gMG across North America, EU & Japan
- The trial met its 1EPs of total IgG reduction from baseline @Day 29 which showed noninferiority of efgartigimod vs Vyvgart with a mean total IgG reduction of 66.4% vs 62.2% from baseline, 69.1% were responders on MG-ADL score & 65.5% on QMG score, MSE was achieved in 37% after 1 treatment cycle. The results were consistent across the overall population
- The safety profile was consistent with the (ADAPT) study & the therapy was generally well-tolerated
Ref: Globenewswire | Image: argenx
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