13 November 2017 - GSK announced today that the European Commission has approved a new subcutaneous formulation of Benlysta (belimumab), as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus with a high degree of disease activity (e.g. positive anti-dsDNA and low complement) despite standard therapy. 

Systemic lupus erythematosus (SLE) is a chronic, incurable, autoimmune disease associated with a range of symptoms that can fluctuate over time, affecting almost any system in the body.

The approval is for a single-dose pre-filled syringe and a single-dose pre-filled pen (auto-injector) presentation, administered as a once weekly injection of 200 mg. These subcutaneous presentations enable patients to self-administer their medicine at home, after initial supervision from their clinical team if considered appropriate. The subcutaneous version of the medicine adds to the existing intravenous formulation, which was licensed for use in Europe in 2011 and has since been used to treat thousands of patients worldwide.

Read GSK press release