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

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 Nervous system diseases 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 Nervous system diseases Myasthenia gravis, AChR antibodies+ 6,300–19,000 100% additional benefit not proven Orphan (turnover limit)
Efgartigimod alfa (1) Vyvgart® Argenx Germany GmbH Nervous system diseases Myasthenia gravis, AChR antibody+ 0
14,000–16,800
100% Hint for considerable additional benefit Orphan repealed


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