FDA Approves Belimumab as First Lupus Nephritis Drug in US


The approval was based on findings from the Belimumab International Study in Lupus Nephritis (BLISS-LN) study.

GlaxoSmithKline (GSK) announced that the US Food and Drug Administration (FDA) approved belimumab (BENLYSTA) for the treatment of adult patients with active lupus nephritis (LN) receiving standard therapy, building on almost 10 years of lupus experience. It is the first biologic to be approved for both systemic lupus erythematosus (SLE) and LN in over 50 years.

LN, an inflammation of the kidneys caused by SLE, may lead to kidney disease, dialysis, or kidney transplant. SLE symptoms include painful or swollen joints, fatigue, fever, skin rashes, and organ damage. “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,” stated Hal Barron, Chief Scientific Officer and President R&D of GSK.

In this phase 3, 104-week, randomized, double-blind, placebo-controlled, post-approval commitment study, Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis (BLISS-LN) evaluated the efficacy and safety of intravenous (IV) BENLYSTA 10 mg/kg in conjunction with standard therapy and found that it was more effective than a placebo (43% vs 32%, odds ratio (95% CI) 1.55 (1.04, 2.32), p=0.0311). Significant results were achieved in 4 major secondary endpoints, including Complete Renal Response and Time to Renal-Related Event or Death. It is the largest and longest study conducted for patients with LN.

Belimumab works as a BLyS-specific indicator, which binds to soluble BLyS in order to inhibit the survival of B cells, which in turn reduces the differentiation of B cells into immunoglobulin-producing plasma cells. It is approved for patients ≥5 years with active, autoantibody-positive SLE who are receiving standard care as well as patients with SLE who are ≥18 years and receiving standard care. It is not recommended for patients with severe active central nervous system lupus and should not be combined with other biologics.

GSK, a company focused on medicines for autoimmune diseases, is the only company with a treatment approval for adult and pediatric lupus. “GSK is leading the way to help patients and their families manage this chronic, inflammatory autoimmune disease. Our aim is to develop transformational medicines that can alter the course of inflammatory disease to help people live their best day, every day,” stated investigators.

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