In Europe, a subcutaneous formulation of belimumab has been approved to help treat patients with active autoantibody-positive systemic lupus erythematosus (SLE). Meanwhile, the U.S. Food and Drug Administration (FDA) has issued a safety alert for febuxostat, after a safety trial showed an increased risk of heart-related death.
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European Commission Approves Subcutaneous Belimumab
A new subcutaneous formulation of belimumab (Benlysta) has been approved by the European Commission.1 The treatment’s approval is as an add-on therapy in adults with active autoantibody-positive SLE with a high degree of disease activity despite standard therapy (e.g., positive anti-dsDNA and low complement). This once-weekly injection will be available in 200 mg single-dose prefilled syringes and single-dose prefilled pens (autoinjector). Belimumab is also available as an existing intravenous formulation.
This approval is based on results of the BLISS-SC Phase 3 study, which included more than 800 patients with active SLE. BLISS-SC measured disease activity reduction at Week 52 in patients who received belimumab plus standard care compared with patients who received placebo plus standard care. This formulation was approved in the U.S. in July 2017.