Efgartigimod Alfa
Active ingredient · 2 therapeutic classes
Sold as VYVGART · VYVGART SC
- Drug class
- Selective Immunosuppressants
- Availability
- See label
- Routes
- Subcutaneous, Intravenous
- Markets covered
- 3
- Products on record
- 6
Overview
Efgartigimod Alfa is an active pharmaceutical ingredient in the Selective Immunosuppressants group (L04AA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 3 | March 20, 2026 |
| CA Canada | Health Canada | 2 | January 28, 2026 |
| EU European Union | EMA | 1 | January 23, 2026 |
GBUnited Kingdom· MHRA
3 products
Uses
Vyvgart is indicated as an add-on to standard therapy for the treatment of adult patients with generalised Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
How to take
CACanada· Health Canada
2 products
Uses
VYVGART® (efgartigimod alfa for injection) is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. 1 Pediatrics Pediatrics (˂ 18 years of age): The safety and efficacy of VYVGART in children and adolescents below the age of 18 years has not been established.
VYVGART is not indicated for use in pediatric patients. 2 Geriatrics Geriatrics (≥ 65 years of age): Eleven (11/84 – 13%) patients aged 65 and over were treated with VYVGART in the placebo-controlled study. The number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger adult patients.
How to take
EUEuropean Union· EMA
1 product
Uses
Vyvgart is indicated as an add-on to standard therapy for the treatment of adult patients with generalised Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
How to take
Sources & citations
- [1]MHRA (UK) · PLGB471040004 · revised October 10, 2025
- [2]Health Canada (DPD) · 02541599 · revised November 14, 2025
- [3]European Medicines Agency · EMEA/H/C/005849 · revised January 23, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.