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.
Pfizer's Hympavzi (marstacimab-hncq) receives US FDA approval for Hemophilia A or B treatment
Capricor begins BLA submission for deramiocel in Duchenne muscular dystrophy
GE HealthCare expands AI-enabled enterprise imaging with Blackford integration
Biogen receives FDA Breakthrough Therapy Designation for felzartamab
Inspira Technologies develops new disposable kit for perfusion market
Ananda Developments PLC signs contract for Phase 1 PK study on MRX1
Teva's Prolia biosimilar candidate accepted for review by FDA and EMA
Boehringer receives Breakthrough Therapy designation for survodutide
GBI Biomanufacturing agrees manufacturing collaboration with Allterum Therapeutics
Genprex research collaborators to present positive data on Reqorsa Gene Therapy at SITC 2024
ALK secures U.S. FDA approval for AccuTest Allergy Skin Testing Devices