Addendum

Nipocalimab (generalized myasthenia gravis) – Addendum to Project A25-160

Report documents

Indication:

Adult and adolescent patients aged 12 years of age and older with generalized myasthenia gravis

Result of dossier assessment:

Adults with anti-acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis for whom add-on therapy to standard treatment is an option: unchanged after addendum: added benefit not proven
Adults with anti-muscle-specific tyrosine kinase (MuSK) antibody-positive generalized myasthenia gravis for whom add-on therapy to standard treatment is an option: unchanged after addendum: added benefit not proven
Adolescents (12 to 17 years) with anti-AChR antibody-positive refractory generalized myasthenia gravis for whom add-on therapy to standard treatment is an option: unchanged after addendum: added benefit not proven
Adolescents (12 to 17 years) with anti-AChR antibody-positive nonrefractory generalized myasthenia gravis or with anti-MuSK antibody-positive generalized myasthenia gravis for whom add-on therapy to standard treatment is an option: unchanged after addendum: added benefit not proven

18-06-2026 A G-BA decision was published.
G-BA documents on this decision

Project no.: A26-51
Commission: Commission awarded on 12.05.2026 by the Federal Joint Committee (GBA).
Report type: Addendum
Status: Commission completed
Department/Division: Drug Assessment
Topic: Head and nerves
Note: If the need for additional work on a project commissioned by the GBA arises during consultations, IQWiG submits an addendum. The subsequent decides on the extent of the added benefit concludes the early benefit assessment.
DOI: https://doi.org/10.60584/A26-51

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