Argenx Secures European Commission Nod for Subcutaneous Vyvgart® (Efgartigimod Alfa) in Treating Generalized Myasthenia Gravis
Friday, November 17, 2023
Argenx SE, a global immunology company listed on Euronext and Nasdaq under the ticker ARGX, has recently obtained approval from the European Commission (EC) for its SC injectable VYVGART (efgartigimod alfa) as an add-on therapy for treating generalized myasthenia gravis (gMG) in adults who test positive for anti-acetylcholine receptor (AChR) antibodies. This approval covers all 27 European Union (EU) Member States, Iceland, Norway, and Liechtenstein, allowing VYVGART to be administered both intravenously (IV) and subcutaneously (SC). The company plans to collaborate with local health authorities to ensure patient access to VYVGART SC in the region.
Argenx EMEA, expressed pride in offering innovative therapies for autoimmune diseases and emphasized the availability of two formulations, including self-administration, providing patients with flexibility in choosing the treatment that best suits their lifestyle.
The EC's decision follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) and is based on favorable results from the Phase 3 ADAPT-SC study. This trial demonstrated the efficacy of VYVGART SC by showing a reduction in anti-AChR antibody levels comparable to VYVGART IV in adult gMG patients. The ADAPT-SC trial was a multicenter, randomized study evaluating the noninferiority of VYVGART SC compared to VYVGART IV in terms of pharmacodynamic effect.
VYVGART SC is a subcutaneously injectable formulation of efgartigimod alfa, a human IgG1 antibody fragment. It utilizes Halozyme's ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. The treatment was approved in the United States in June 2023 under the name VYVGART® Hytrulo.
Generalized myasthenia gravis is a rare autoimmune disease characterized by IgG autoantibodies disrupting nerve-muscle communication, leading to severe muscle weakness. VYVGART aims to reduce circulating IgG autoantibodies by binding to the neonatal Fc receptor (FcRn).
Source: globenewswire.com
