NEW YORK, NY. December 17, 2020. The Lupus Research Alliance (LRA) congratulates GSK on the U.S. Food and Drug Administration (FDA) approval of belimumab (Benlysta^®) as the first-ever treatment specifically indicated for lupus nephritis (LN) in adults. 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.

“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
Lupus nephritis is inflammation of the kidney that occurs as a common symptom of systemic lupus erythematosus (SLE), also known as lupus. Proteins in the immune system called antibodies damage important structures in the kidney.  Lupus nephritis is the most common complication of lupus. Five out of 10 adults with lupus will have lupus nephritis, while eight out of 10 children with lupus will have kidney damage, which usually stems from lupus nephritis. LN is more common among women than men and particularly among those who are Black, Latinx, and/or Asian^.[i]

Click here for the announcement from GSK.

About Lupus
Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. More than 90 percent of people with lupus are women; lupus most often strikes during the childbearing years of 15-45. African Americans, Latinx, Asians and Native Americans are two to three times at greater risk than Caucasians. In lupus, the immune system, which is designed to protect against infection, creates antibodies that can attack any part of the body including the kidneys, brain, heart, lungs, blood, skin, and joints.

About the Lupus Research Alliance
The Lupus Research Alliance is the largest non-governmental, non-profit funder of lupus research worldwide. The organization aims to transform treatment by funding the most innovative lupus research, fostering diverse scientific talent, and driving discovery toward better diagnostics, improved treatments and ultimately a cure for lupus. Because the Lupus Research Alliance’s Board of Directors fund all administrative and fundraising costs, 100% of all donations goes to support lupus research programs.

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[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%20 kidney%20disease. Accessed 7.22.20