Saturday, July 01, 2023
Argenx and Zai Lab have announced that the Biologics Licence Application (BLA) for VYVGART® (efgartigimod alfa injection) has been approved by China's National Medical Products Administration (NMPA).
VYVGART is a first-in-class neonatal Fc receptor (FcRn) antagonist and is intended to be used as an add-on therapy for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
VYVGART is a human IgG1 antibody fragment that targets the neonatal Fc receptor, resulting in the reduction of circulating IgG autoantibodies. It is the first approved FcRn blocker for the treatment of gMG in the United States, European Union, and China.
This approval marks an important milestone in the treatment of gMG in China. Clinical studies have shown that efgartigimod has remarkable onset of action, efficacy, and safety profiles, leading to improvements in muscle strength and quality of life for patients.