Argenx Reports EMA’s Validation of MAA for Efgartigimod to Treat Generalized Myasthenia Gravis

August 25, 2021 Auto Bot Argenx, EMA, MAA, regulatory 0

Shots:

  • The MAA is based on the P-III ADAPT trial evaluating the safety and efficacy of efgartigimod vs PBO in a ratio (1:1) in 167 adult patients with gMG for 26wks.
  • The 1EPs was the proportion of AChR-Ab+ patients who achieved a response on the MG-ADL score defined by at least a two-point improvement for ≥4wks. consecutively
  • If approved, the therapy will be the 1st approved FcRn antagonist in the EU & is currently under FDA’s review for gMG with an anticipated PDUFA date as Dec 17, 2021. Additionally, the company has submitted the application to PMDA in early 2021

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