Policy & Regulation
argenx SE receives positive CHMP opinion for SC efgartigimod in gMG
15 September 2023 -

Immunology company argenx SE (Euronext Brussels:ARGX) (Nasdaq:ARGX) announced on Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended European Commission approval of the subcutaneous (SC) injectable formulation of efgartigimod.

This recommendation is for use as an add-on therapy for adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. Efgartigimod is formulated with US biotechnology company Halozyme's (Nasdaq:HALO) ENHANZE drug delivery technology.

The CHMP's decision was based on in positive results from the Phase 3 ADAPT-SC study, in which SC efgartigimod demonstrated non-inferior total IgG reduction at day 29 compared to intravenous (IV) administration. Notably, the mean total IgG reduction was 66.4% for SC efgartigimod versus 62.2% for the IV formulation. The trial also achieved key secondary endpoints consistent with clinical benefit measures in gMG.

SC efgartigimod exhibits a safety profile in line with the ADAPT IV clinical trial, except for mild to moderate injection site reactions (ISRs), a common occurrence with subcutaneously administered biologics. ISRs did not lead to treatment discontinuation.

The European Commission is expected to issue its decision within approximately 60 days, impacting the 27 European Union member states and also Iceland, Norway and Liechtenstein.