Policy & Regulation
Argenx secures European Commission approval for VYVGART SC in gMG
16 November 2023 -

Immunology company argenx SE (Euronext Brussels:ARGX) (Nasdaq:ARGX) announced on Thursday that it has received approval from the European Commission for subcutaneous injectable VYVGART (efgartigimod alfa) as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

The EC previously approved VYVGART for intravenous (IV) use in August 2022.

This latest decision follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) and was based on positive results from the Phase 3 ADAPT-SC study.

The approval applies to all 27 European Union Member States plus Iceland, Norway and Liechtenstein.

VYVGART SC, a subcutaneous injectable formulation of efgartigimod alfa, incorporates Halozyme's ENHANZE drug delivery technology to facilitate SC injection delivery of biologics. By binding to the neonatal Fc receptor (FcRn), VYVGART leads to a reduction in circulating IgG autoantibodies.