Posted by Michael Wonder on 21 Sep 2022
argenx submits biologics license application to US Food and Drug Administration for subcutaneous efgartigimod for treatment of generalised myasthenia gravis
21 September 2022 - Submission package based on positive data from the Phase 3 ADAPT-SC trial demonstrating non-inferiority of subcutaneous efgartigimod compared to intravenously administered Vyvgart (efgartigimod alfa-fcab) based on total immunoglobulin G reduction at day 29.
argenx today announced the submission of a biologics license application to the U.S. FDA for subcutaneous efgartigimod (1000mg efgartigimod-PH20) for the treatment of generalised myasthenia gravis in adult patients.
