Benlysta (belimumab)
- Region
- 🇪🇺 EU
- Active substance
- belimumab
- Company
- GlaxoSmithKline (Ireland) Limited
- Status
- Authorised
- Therapeutic area
- Lupus Erythematosus, Systemic
- CHMP opinion
- Thu 19 May 2011
- EU approval
- Wed 13 Jul 2011
- Application
- EMEA/H/C/002015
- ATC
- L04AG04
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.