argenx Reports the US FDA Acceptance of BLA for Efgartigimod to Treat Generalized Myasthenia Gravis
Shots:
- 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
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
