Argenx — Vyvgart EMA EPAR variation assessment report (EMEA/H/C/005849, 2022)
Argenx · 2022 · EMA EPAR variation assessment report · company profile →
Report summary
Argenx received EMA approval for a Vyvgart (efgartigimod alfa) marketing authorization extension, introducing a new 1000 mg subcutaneous (SC) formulation for anti-acetylcholine receptor (AChR) antibody-positive generalized Myasthenia Gravis (gMG) patients. The approval, based on a positive CHMP opinion, follows comprehensive quality, non-clinical, and clinical assessments. Studies demonstrated the SC formulation's non-inferiority to the intravenous (IV) form in reducing total IgG levels and achieving comparable clinical efficacy. While the SC formulation showed higher rates of injection site reactions, its overall safety profile was acceptable, with ongoing studies to gather long-term data. The manufacturing process and stability were confirmed, supporting a 24-month shelf-life.
Key findings — cited to the page
| Grade 4 lymphocyte count decreased | 1 participant | SC Pooling Block · p.133 |
| Grade 4 lymphocyte count decreased | 1 participant | ARGX-113-2002 · p.132 |
| Grade 3 hypertriglyceridemia | 2 patients | ARGX-113-2001 · p.132 |
| Grade 3 lymphocyte count decreased | 7.3 % | SC Pooling Block · p.133 |
| Grade 3 lymphocyte count decreased | 12 participants | ARGX-113-2002 · p.132 |
| Grade 3 lymphocyte count decreased | 7.5 % | ARGX-113-2002 · p.132 |
| Grade 3 clinical laboratory abnormalities of lymphocyte count decreased | 5 participants | ARGX-113-2001 · p.132 |
| Grade 4 lymphocyte count decreased | 0.6 % | ARGX-113-2002 · p.132 |
| Grade 3 hypertriglyceridemia | 1 patient | ARGX-113-2002 · p.132 |
| Grade 3 lymphocyte count decreased | 12 participants | SC Pooling Block · p.133 |
| Grade 3 clinical laboratory abnormalities of lymphocyte count decreased | 4.5 % | ARGX-113-2001 · p.132 |
| Grade 4 lymphocyte count decreased | 0.6 % | SC Pooling Block · p.133 |
Source: Argenx ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →