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argenx Receives the EMA’s CHMP Positive Opinion of Efgartigimod for Generalized Myasthenia Gravis

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argenx Receives the EMA’s CHMP Positive Opinion of Efgartigimod for Generalized Myasthenia Gravis

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  • 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

Related News:- argenx's Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Receives the US FDA’s Approval for Generalized Myasthenia Gravis

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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.

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