LRA Pleased to Share GSK's Benlysta® (belimumab) is First Lupus Nephritis Treatment Approved by FDA
NEW YORK, Dec. 17, 2020 /PRNewswire/ -- The Alliance For Lupus Research (LRA) congratulates GSK on the U.S. Food and Drug Administration (FDA) approval of belimumab (Benlysta®) as the first-ever treatment indicated specifically for adults with lupus nephritis (LN), a complication of systemic lupus erythematosus (SLE). 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 SLE, lupus nephritis is inflammation of 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.
"An effective treatment developed specifically for lupus nephritis has been desperately needed," commented Lupus Research Alliance President and CEO Kenneth M. Farber. "We are particularly proud to see this approval for another indication of belimumab, having funded much of the original research that led to the drug's development. We at the LRA are thrilled to share this news about belimumab and look forward to future approvals of other lupus nephritis treatment options."
The approval is based on positive results of the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) showing belimumab as a safe and effective therapy for treating lupus nephritis.
Both of the trial's lead investigators are advisors to the Lupus Clinical Investigators Network (LuCIN) managed by LRA affiliate Lupus Therapeutics: Dr. Richard Furie, Chief of the Division of Rheumatology at the Feinstein Institutes for Medical Research at Northwell Health and Dr. Brad Rovin, Director of the Division of Nephrology and Medical Director of the Center for Clinical Research Management at the Ohio State University Wexner Medical Center.
Half of all people with lupus nephritis do not realize that, by definition, they also have lupus, according to a recent survey of patients and healthcare professionals conducted by the Lupus Research Alliance in collaboration with the National Kidney Foundation. Survey results also found that for half of patients, diagnosis with lupus nephritis came before lupus was identified.
About Lupus Nephritis
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About Lupus Research Alliance
i Lupus and Kidney Disease (Lupus Nephritis). National Institute of Diabetes and digestive and Kidney Diseases. https://www.niddk.nih.gov/healthinformation/kidney-disease/lupus-nephritis#:~:text=2-,How%20common%20is%20lupus%20nephritis%3F,10%20will%20have%20kidney%20disease. Accessed 7.22.20
SOURCE Lupus Research Alliance