GSK obtains FDA blessing for new indication for Benlysta

The Food and Drug Administration has given the green light to GlaxoSmithKline for Benlysta (belimumab) for the treatment of adult patients with active lupus nephritis who are receiving standard therapy.

Lupus nephritis is a serious inflammation of the kidneys caused by systemic lupus erythematosus, or SLE, the most common form of lupus, which can lead to end-stage kidney disease, requiring dialysis or a kidney transplant. The approval extends the current indication in the United States to include both SLE and LN for both the intravenous and subcutaneous formulations.

"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 Hal Barron, GSK chief scientific officer and president R&D.

First approved in 2011, the medication is the first and only approved biologic for both SLE and LN in more than 50 years. 

Benlysta is indicated for patients aged ≥5 years with active, autoantibody-positive SLE who are receiving standard therapy and patients aged ≥18 with active lupus nephritis who are receiving standard therapy. The subcutaneous formulation is approved for patients aged ≥18 years.