Uplizna - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

inebilizumab

Opinion

On 18 September 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Uplizna. The marketing authorisation holder for this medicinal product is Amgen Europe B.V.

The CHMP adopted a new indication as follows:

Immunoglobulin G4-related disease (IgG4-RD)

Uplizna is indicated for the treatment of adult patients with active IgG4-RD (see section 5.1).

For information, the full indications for Uplizna will be as follows:¹

Neuromyelitis optica spectrum disorders (NMOSD)

Uplizna is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive (see section 5.1).

Immunoglobulin G4-related disease (IgG4-RD)

Uplizna is indicated for the treatment of adult patients with active IgG4-RD (see section 5.1).

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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¹New text in bold, removed text as strikethrough.

CHMP post-authorisation summary of positive opinion for Uplizna

Adopted Reference Number: EMA/CHMP/290671/2025

Key facts

• Name of medicine:
  Uplizna
• EMA product number:
  EMEA/H/C/005818
• Active substance:
  Inebilizumab
• International non-proprietary name (INN) or common name:
  inebilizumab
• Therapeutic area (MeSH):
  Neuromyelitis Optica
• Anatomical therapeutical chemical (ATC) code:
  L04AA
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Marketing authorisation holder:
  Amgen Europe B.V.
• Date of opinion:
  18/09/2025
• Status:
  Positive