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

Click hereRef: GlobeNewswire | Image: Cowen