FDA approves first treatment for adult patients with active lupus nephritis

The US Food and Drug Administration approved the intravenous and subcutaneous formulations of belimumab (Benlysta; GSK) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy, according to a press release.

Belimumab was previously approved for the treatment of patients ≥5 years old with systemic lupus erythematosus (SLE).

Approval is based on the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) study, which included 448 adult patients with LN. In the study, 43% of patients treated with belimumab plus standard therapy achieved Primary Efficacy Renal Response (PERR) at 2 years compared to 32% of patients treated with placebo plus standard therapy (P = 0.0311).

“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,” said Dr Hal Barron, Chief Scientific Officer and President R&D, GSK in a press release.

Read the full press release here.