argenx Reports Results of Vyvgart (efgartigimod alfa-fcab) in P-III (ADAPT-SC) Study for the Treatment of Generalized Myasthenia Gravis
Shots:
- The P-III (ADAPT-SC) study evaluates efgartigimod (1000mg, SC) vs efgartigimod (IV, 10mg/kg) in a ratio (1:1) in 110 patients with gMG across North America, EU & Japan for 12wks. including 7wks. of follow-up after the treatment cycle
- The study met its 1EPs & 2Ps i.e., the therapy showed a non-inferior total IgG reduction (66.4% vs 62.2%) @29 Day. The results were consistent across the overall population including AChR Abs
- The 2EPs showed clinical improvement consistent with IV administration, 69.1% were responders on MG-ADL score & 65.5% on QMG score, the onset of effect & minimal symptom expression was consistent with (ADAPT) study. The company plans to submit a BLA to the US FDA at the end of 2022
Ref: Businesswire | Image: Globe Newswire
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