GSK’s Benlysta® (belimumab) is First Lupus Nephritis Treatment Approved by FDA
The U.S. Food and Drug Administration (FDA) in late December 2020 approved Benlysta® to treat lupus nephritis (lupus-related kidney disease) in adults. The decision makes Benlysta the first lupus therapy authorized to treat this potentially life-threatening complication of the disease.
Another milestone, this new indication is the only FDA approval of a new lupus treatment since belimumab was first approved for systemic lupus erythematosus in 2011.
One of the most common and serious complications of systemic lupus erythematosus, lupus nephritis is inflammation in the kidneys. Too often, this damage necessitates regular dialysis or a transplanted organ to do the work of the kidneys in filtering wastes from the body.
“The FDA’s approval of Benlysta for lupus nephritis represents an important milestone in treating one of the most serious consequences of lupus,” said Stevan W. Gibson, president and CEO, Lupus Foundation of America. “Between 10 and 30 percent percent of people with lupus nephritis will develop end-stage renal disease or kidney failure. Effective treatment can greatly improve health outcomes and reduce the long-term costs associated with managing lupus-related kidney disease.”
The recent approval by the FDA follows on from the Pharmaceutical Benefits Advisory Committee (PBAC) decision in October 2020 to reject Benlysta being included on the Pharmaceutical Benefits Scheme. This is the second submission to the PBAC that has been rejected despite attempts put forward to mitigate the uncertainties identified.
Lupus Australia remains disappointed by the PBAC’s decision not to recommend Benlysta® (belimumab) administered subcutaneously for the treatment of patients with systemic lupus erythematosus (SLE), given this is the only new therapy to be approved by the Therapeutic Goods Administration for this indication in 50 years.