Benlysta
What Benlysta is used for
Benlysta is indicated as add-on therapy in 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. Benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis. Benlysta is indicated as add-on therapy in adult patients 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.
Approved use, as published by the European Medicines Agency.
Key facts
- Brand
- Benlysta
- Active substance
- belimumab
- Disease area
- Lupus Erythematosus, Systemic
- Medicine group
- Immunosuppressants
- ATC code
- L04AG04
- Marketing authorisation holder
- GlaxoSmithKline (Ireland) Limited
- Authorised in the EU since
- 2011
Official information
In the USA
Same active substance: Benlysta
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Benlysta used for?
Benlysta is indicated as add-on therapy in 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. Benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis. Benlysta is indicated as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti dsDNA and…
What is the active substance in Benlysta?
Benlysta contains belimumab.
Who makes Benlysta?
The EU marketing authorisation holder is GlaxoSmithKline (Ireland) Limited.
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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