Argenx — Vyvgart EMA EPAR variation assessment report (EMEA/H/C/005849, 2022)
Argenx · 2022 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the CHMP's assessment of Argenx's application for an extended indication of Vyvgart (efgartigimod alfa) for adult patients with active chronic inflammatory demyelinating polyneuropathy (CIDP). The application, supported by the ARGX-113-1802 and ARGX-113-1902 studies, demonstrated significant efficacy, with 66.5% of patients showing clinical improvement and a reduced risk of deterioration compared to placebo. Pharmacokinetic, pharmacodynamic, and immunogenicity data were acceptable. The safety profile, consistent with previous findings, showed no new concerns, with common adverse events being infections. The CHMP recommended approval, acknowledging the positive benefit-risk balance despite some trial design limitations and ongoing post-authorization safety studies.
Key findings — cited to the page
| Participants with grade 4 AESIs | 3 participants | · p.131 |
| Participants with grade 4 COVID-19 | 1 participant | · p.131 |
| Participants with grade 2 AESIs | 63 participants | · p.131 |
| Percentage of participants with grade 3 AESIs | 2.7 % | · p.131 |
| Participants with grade 4 Appendicitis | 1 participant | · p.131 |
| Percentage of participants with grade 4 Appendicitis | 0.3 % | · p.131 |
| Participants with grade 1 AESIs | 59 participants | · p.131 |
| Percentage of participants with grade 1 AESIs | 17.9 % | · p.131 |
| Percentage of participants with grade 2 AESIs | 19.1 % | · p.131 |
| Participants with grade 3 AESIs | 9 participants | · p.131 |
| Percentage of participants with grade 4 AESIs | 0.9 % | · p.131 |
| Percentage of participants with grade 4 COVID-19 | 0.3 % | · p.131 |
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 →