S.L.E. Lupus Foundation Hails First FDA-Approved Drug for Lupus in 50 Years

One of Nation’s First Lupus Organizations Reflects on Landmark Approval

March 9, 2011 — The New York City-based S.L.E. Lupus Foundation and its West Coast division Lupus LA welcome the U.S. Food and Drug Administration’s (FDA) historic approval of BENLYSTA® (belimumab) for systemic lupus erythematosus (lupus), which is now the first new treatment approved for the chronic autoimmune disease in more than half a century.

“I’ve been waiting for this day since I was diagnosed with lupus more than 40 years ago,” said Susan Golick, co-founder of the S.L.E. Lupus Foundation. “When my parents Morrie and Dorothy and I started this organization in 1970, lupus was often a death sentence. We made it our mission to be a motivating force to the patient and medical communities, working to improve the lives of people with lupus while fighting for a cure. It’s been a long and frustrating journey, but we haven’t given up, and now we can be confident that industry and scientists aren’t giving up either. This is the start of a new era.” 

The FDA announced on Wednesday that BENLYSTA, developed by Human Genome Sciences (HGS) and GlaxoSmithKline (GSK), is approved for treatment of people with active systemic lupus. This decision followed its Arthritis Advisory Committee’s 13-2 vote on November 16, 2010 to recommend the drug’s approval.

BENLYSTA is the first targeted biological agent developed specifically for systemic lupus. Through multiple clinical trials, the drug proved to be effective in ameliorating the signs and symptoms of lupus, with few side effects. With its use, many study participants were also able to lessen their use of damaging corticosteroids (prednisone) and other medicines. s.

“After decades of suffering from harsh drugs with devastating side effects, people with lupus now have real options for safer and more effective treatments,” added the Foundation’s Executive Director Margaret Dowd. “This is a huge step forward for the lupus community and a victory for the 1.5 million Americans who struggle with lupus daily. Now we can stop looking back on the dearth of treatments over the past decades, and look forward to new research and accelerated drug development that will give us myriad therapies, more precise care, and a cure.”

“The wait is over, and the lupus community can now rejoice over today's historic approval, which marks a major milestone in lupus research and treatment,” said Richard Furie, MD, chief of the division of rheumatology and allergy-clinical rheumatology at North Shore-LIJ Health System in New York. “Not only does this approval add a new medication to the physician's toolbox, but it will also serve as a catalyst for yet more sorely needed drug research and development in lupus.”