EU approves new subcutaneous form of lupus treatment

The European Commission has approved a new subcutaneous formulation of Benlysta (belimumab), from GSK, as an 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.

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 prefilled syringe and a single-dose prefilled pen (autoinjector) presentation, administered as a once weekly injection of 200mg. These SC 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 (IV) formulation, which was licensed for use in Europe in 2011 and has since been used to treat thousands of patients worldwide.

The approval is based on results from the BLISS-SC phase III pivotal study of more than 800 patients with active SLE, published earlier this year in Arthritis & Rheumatology. The study measured reduction in disease activity at Week 52 in patients receiving Benlysta plus standard of care, versus those receiving placebo plus standard of care (assessed by SRI, a composite measure of efficacy in lupus).

Comment: the Benlysta subcutaneous formulation was approved for use in the US in July 2017 and Japan in September 2017 and further regulatory submissions are under review or planned in other countries.