FDA approves first lupus nephritis treatment

GlaxoSmithKline (GSK) today announced that the FDA has approved Belysta (belimumab) extended adaptation for the treatment of active lupus nephritis (LN) adult patients undergoing standard therapies.
lupus nephritis is a severe inflammation of the kidneys caused by systemic lupus erythematosus (SLE), which can lead to end-stage kidney disease and require dialysis or kidney transplantation.
press release that this is the first FDA-approved treatment for lupus nephritis.
systemic lupus is the most common type of lupus, a chronic, incurable autoimmune disease.
symptoms include joint pain or swelling, extreme fatigue, unexplained fever, rash and organ damage.
lupus nephritis, the immune system attacks the kidneys, causing inflammation of small blood vessels that filter waste from the kidneys, and symptoms such as proteinuria, elevated serum creatinine, and urine residue.
despite improvements in diagnosis and treatment over the past few decades, lupus nephritis remains an indicator of poor prognosis.
Benlysta is a monoclonal antibody that binds to soluble B lymphocyte stimulation factor (BLyS).
Benlysta does not bind directly to B cells, and by binding to BLyS, it inhibits the survival of B cells, including autoimmune B cells, and reduces the differentiation of B cells into plasma cells that produce immunoglobulins.
first approved in 2011, Belysta is the first and only biological product approved for the treatment of systemic lupus and lupus nephritis in more than 50 years.
FDA approval is based on the positive results of a randomized double-blind, placebo-controlled Phase 3 clinical trial, BLISS-.
trial included 448 adult patients.
trial results showed a significant increase in the proportion of patients in the placebo-plus standard treatment group (43%) who achieved primary therapeutic renal remission (Primary Efficacy Renal Response, PERR) after the second year of treatment compared to placebo plus standard treatment (32%).
, all four major secondary endpoints achieved statistically significant results compared to placebo, including full renal remission and the time required for kidney-related events or deaths.
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