Posted by Michael Wonder on 16 Sep 2023
argenx announces positive CHMP opinion for subcutaneous efgartigimod for generalised myasthenia gravis
15 September 2023 - Positive opinion based on Phase 3 ADAPT-SC study demonstrating non-inferior total IgG reduction at day 29 with subcutaneously administered efgartigimod, compared to intravenous administration.
argenx today announced that the CHMP of the EMA has recommended European Commission approval of the subcutaneous injectable formulation of efgartigimod as an add on to standard therapy for the treatment of adult patients with generalised myasthenia gravis who are anti acetylcholine receptor antibody positive.
