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 not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2021) — Sources
• EMA — Approved (2022) — Sources
• NMPA — Approved (2023) — Sources

Pivotal Clinical Evidence

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

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/