VYVGART efgartigimod alfa

Drug Class

Neonatal Fc receptor (FcRn) blocker

Mechanism

Efgartigimod alfa is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), blocking FcRn from recycling IgG and accelerating the degradation of pathogenic autoantibodies.

Approved Indication

Treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

What This Means For Patients

Vyvgart is an FcRn blocker approved for the treatment of generalized myasthenia gravis (gMG). It works by targeting the receptor that recycles IgG antibodies, reducing the levels of harmful antibodies driving muscle weakness. Following regulatory approvals by the FDA, EMA, and China's NMPA (brand name 卫伟迦), it is clinically available in the Hainan Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2021) — label
• EMA — approved (2022) — source
• NMPA — approved (2023) — source

Pivotal Clinical Evidence

• ADAPT — Howard et al., Lancet Neurol 2021 (NCT03693625) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761204s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/vyvgart
• http://www.nmpa.gov.cn/