Lupus nephritis, an inflammation of the kidneys caused by systemic lupus erythematosus (SLE), may lead to end-stage kidney disease. Benlysta, a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS.
The FDA nod expands the present indication in the US to include both SLE and LN for both the intravenous and subcutaneous formulations.
The FDA approval for adult patients with active LN, which follows a breakthrough therapy designation and priority review, is based on data from the BLISS-LN study.
According to the company, the study achieved its primary endpoint showing that a statistically significant greater number of patients reached primary efficacy renal response (PERR) at two years when treated with Benlysta plus standard therapy compared to placebo plus standard therapy in adults with active LN.
BLISS-LN is a phase 3, 104-week, randomised, double-blind, placebo-controlled and post-approval commitment study designed to assess the efficacy and safety of intravenous (IV) Benlysta 10mg/kg plus standard therapy compared to placebo plus standard therapy in adult patients with active LN.
GSK R&D president and chief scientific officer Dr Hal Barron said: “Approximately 40% of patients with systemic lupus erythematosus develop lupus nephritis, which causes inflammation in the kidneys and can lead to end-stage kidney disease.
“Benlysta is the first medicine approved to treat systemic lupus and adults with active lupus nephritis, an important treatment advance for patients with this incurable autoimmune disease.”
In September this year, GSK secured approval from the FDA for its Nucala (mepolizumab) for the treatment of hypereosinophilic syndrome (HES), a rare and under-diagnosed disorder.