The U.S. Food and Drug Administration (FDA) has approved Benlysta® to treat lupus nephritis (lupus-related kidney disease) in adults. The approval is for both the intravenous and subcutaneous formulations. The decision makes Benlysta the first lupus therapy authorized to treat this potentially life-threatening complication of the disease. Up to 60 percent of people with lupus will develop lupus nephritis.

Benlysta is a human monoclonal antibody sold by GSK. The FDA first approved Benlysta for lupus in 2011. However, at that time, Benlysta had not been studied for use in individuals with severe lupus nephritis.

Last year, GSK announced positive results from a two-year clinical trial involving several hundred people with active lupus nephritis treated with Benlysta. This is the most extensive controlled phase 3 study in active lupus nephritis, demonstrating that Benlysta could make a clinically meaningful improvement. 

Additional information about today's FDA decision is available through the GSK media release

"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 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."

Dr. Susan M. Manzi, Lupus Foundation of America Board Chair and Medical Director and Chair, Allegheny Health Network Medicine Institute and Director, Lupus Center of Excellence, noted that the approval is a big win for physicians and their patients. "Standard-of-care treatment for lupus nephritis has relied upon using strong immunosuppressant drugs and high doses of corticosteroids.  These medications can take a considerable toll on the body," said Dr. Manzi. "As clinicians, we welcome the option to use Benlysta, which has a favorable safety profile while delivering results with less risk from the side effects associated with legacy lupus nephritis treatments."

Learn more about lupus nephritis from the National Resource Center on Lupus.  

Wendy Rodgers was diagnosed with lupus nephritis in 2000 and underwent dialysis for nine years while awaiting a kidney transplant. "Today's news from GSK means people with lupus nephritis have a better chance to maintain good kidney function and avoid the drastic measures I had to endure," said Rodgers, who advocates on behalf of people with lupus. "I'm very excited there is a more tolerable and effective option available for treating lupus nephritis."

The Lupus Foundation of America has a long history of working to improve care and treatment for people living with lupus nephritis treatments. "Because of its potentially devastating impact on the quality of life for people with lupus, the Foundation has funded many important lupus nephritis research studies," noted Dr. Karen H. Costenbader, Director of the Lupus Program at Brigham and Women's Hospital in Boston and chair of the Lupus Foundation of America's Medical-Scientific Advisory Council. "The Foundation continues robust efforts to support research on lupus nephritis in adults and especially in children and teens who face a lifetime of treatment."

In addition to directly funding medical research on lupus nephritis, the Foundation's public policy initiatives helped secure nearly $2 million to support research on lupus and the kidneys through the U.S. Department of Defense Medical Research Program.

The Foundation also supports clinical research and clinical trials through its online data platform, RAY™ (Research Accelerated by You), where people with lupus and caregivers share information about their lupus experiences to help researchers accelerate the development of new treatments and improve disease outcomes. 

In addition to today's good news about Benlysta, the FDA is nearing a January decision deadline for another potential treatment for lupus nephritis, voclosporin. Last year, Aurinia Pharmaceutical Company released positive data from two large-scale phase 3 clinical studies of voclosporin, which met all primary and secondary endpoints with a clean safety profile.

Voclosporin blocks the ability of the enzyme calcineurin to activate T cells. If the FDA also approves voclosporin, there will be two new options for physicians to manage lupus nephritis, one of the leading causes of disability and mortality in lupus, providing people with the opportunity for a much-improved quality of life.