argenx Receives the EMA’s CHMP Positive Opinion of Efgartigimod for Generalized Myasthenia Gravis
- The EMA’s CHMP has recommended approval of efgartigimod (SC) as an add-on to standard therapy for adult patients with gMG who are AChR Ab+. The EC’s decision on MAA is expected within ~60 days
- The opinion was based on the P-III study (ADAPT-SC) evaluating efgartigimod (SC) vs efgartigimod (IV) in a ratio (1:1) in 110 adult patients in North America, EU & Japan
- The trial met its 1EPs of noninferiority & showed a mean total IgG reduction of 66.4% vs 62.2% from baseline at 29 Days. The 2EPs were also met which were consistent with efficacy measures from the (ADAPT IV) study, identifying the correlation b/w IgG reduction & clinical benefit. The EC’s decision will be valid for all 27 EU Member States, Iceland, Norway & Liechtenstein
Ref: Globenewswire | Image: argenx
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