Efgartigimod alfa (3) – Vyvgart®
Chronic inflammatory demyelinating polyneuropathy, in patients who have received prior treatment
Characteristics
| Start date | 01.08.2025 – Marketing authorisation: 19.06.2025 |
|---|---|
| Resolution | 22.01.2026 |
| INN | Efgartigimod alfa |
| Brand name | Vyvgart® |
| Pharm. company | Argenx Germany GmbH |
| G-BA Procedure ID | D-1234 |
| ATC code | L04AL01 IMMUNOSUPPRESSANTS (L04A) |
| ICD-10 codes (AIS) | G61.8Other inflammatory polyneuropathies |
| Alpha-ID codes (AIS) | I87775CIDP (chronic inflammatory demyelinating polyneuropathy) |
| ORPHAcodes (AIS) | 2932CIDP (chronic inflammatory demyelinating polyneuropathy) |
| Therapeutic area | Nervous system diseases Orphan (turnover limit) |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
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Vyvgart is used as monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) following prior treatment with corticosteroids or immunoglobulins. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Erwachsene mit progredienter oder rezidivierender aktiver chronisch-entzündlicher demyelinisierender Polyneuropathie (CIDP) nach vorheriger Behandlung mit Kortikosteroiden oder Immunglobulinen |
Studies and Results
- Clinical trials
- The ADHERE study is a multi-stage Phase II trial designed to investigate the safety and efficacy of efgartigimod alfa for the treatment of CIDP.
- In the subsequent double-blind, randomised and controlled phase (Stage B), patients received efgartigimod alfa or placebo.
Adults with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) following prior treatment with corticosteroids or immunoglobulins
- For adults with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) following prior treatment with corticosteroids or immunoglobulins, the additional benefit is not proven.
- The additional benefit of efgartigimod alfa compared with the appropriate comparator therapy in adults with progressive or relapsing active CIDP following prior treatment with corticosteroids or immunoglobulins is not proven.
- Conclusion
- Overall, the data presented are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy.
- Additional benefit from efgartigimod alfa for the treatment of adults with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) is not proven following prior treatment with corticosteroids or immunoglobulins.
Courtesy translation only, please refer to the German original.
Associated procedures
| Efgartigimod alfa (3) | Vyvgart® | Argenx Germany GmbH | Chronic inflammatory demyelinating polyneuropathy, in patients who have received prior treatment | 50–260 | 100% additional benefit not proven Orphan (turnover limit) | |
| Efgartigimod alfa (2) | Vyvgart® | Argenx Germany GmbH | Myasthenia gravis, AChR antibodies+ | 6,300–19,000 | 100% additional benefit not proven Orphan (turnover limit) | |
| Efgartigimod alfa (1) | Vyvgart® | Argenx Germany GmbH | Myasthenia gravis, AChR antibody+ |
0
14,000–16,800 |
100% Hint for considerable additional benefit Orphan repealed |
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