Benlysta - opinion on variation to marketing authorisation

Opinion

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

belimumab

Opinion

On 19 June 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 Benlysta. The marketing authorisation holder for this medicinal product is GlaxoSmithKline (Ireland) Limited.

The CHMP adopted a change to an existing indication for Benlysta solution for injection in pre-filled pen, as follows:^1,/sup>

Benlysta is indicated as add-on therapy in adult patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy (see section 5.1).

Benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (see sections 4.2 and 5.1).

For patients under 10 years of age, Benlysta pre-filled pen must be administered by a healthcare professional or trained caregiver.

Indications for Benlysta solution for injection in pre-filled syringes and Benlysta powder for concentrate for solution for infusion remain unchanged and are provided in the summary of product characteristics (SmPC).

Detailed recommendations for the use of this product will be described in the updated 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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¹ New text in bold, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for Benlysta (II-133)

AdoptedReference Number: EMA/CHMP/177699/2025

Key facts

• Name of medicine:
  Benlysta
• EMA product number:
  EMEA/H/C/002015
• Active substance:
  belimumab
• International non-proprietary name (INN) or common name:
  belimumab
• Therapeutic area (MeSH):
  Lupus Erythematosus, Systemic
• Anatomical therapeutical chemical (ATC) code:
  L04AG04
• 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:
  GlaxoSmithKline (Ireland) Limited
• Date of opinion:
  19/06/2025
• Status:
  Positive