Today the U.S. Food and Drug Administration (FDA) Arthritis Advisory Committee voted overwhelmingly (13 to 2) to recommend BENLYSTA® for approval as a treatment for the autoimmune disease lupus. If FDA approved, BENLYSTA would become the first new treatment for lupus in 52 years. While today’s vote is a positive step, the FDA still must make a final decision to approve BENLYSTA in the coming weeks.
Sandra C. Raymond, President and Chief Executive Officer of the Lupus Foundation of America (LFA) issued the following statement after the Committee’s vote:
“We are pleased to share the exciting news that BENLYSTA has cleared a significant hurdle on its path to becoming the first FDA-approved medication for lupus in 52 years – since Dwight D. Eisenhower was president. BENLYSTA is now on track to become the first approved treatment ever developed specifically for lupus.
Today’s historic vote by the FDA Advisory Committee is not only a victory for developers Human Genome Sciences and GlaxoSmithKline, but also for the entire lupus research community and industry. We have all worked for decades to overcome many challenges in developing new therapies for this unique and difficult-to-treat disease. For people with lupus, today’s vote represents a beacon of hope that new and improved treatments can be specifically developed for lupus.
The voices of people with lupus were heard loudly and clearly today. Their testimony demonstrated the urgent need to develop new, safe, effective, and tolerable therapies for lupus. Each person with lupus is unique, and if BENLYSTA is approved, it would be a significant and necessary first step towards creating the full arsenal of treatments that lupus requires. The LFA thanks the committee for its time and review to ensure the safety and efficacy of this potential medication for people with lupus. We also want to thank the numerous individuals with lupus and their families, who provided testimony and attended the hearing to show their support.
We are greatly encouraged by today’s vote, and eagerly await the FDA’s final decision. The LFA will continue to follow this process closely, and keep constituents apprised of developments.”
About the Lupus Foundation of America
The Lupus Foundation of America (LFA) is the foremost national nonprofit organization dedicated to finding the causes of and cure for lupus, and providing support, services, and hope to all people affected by lupus. The LFA and its national network of chapters, support groups, and local representatives conduct programs of research, education, and advocacy.
Lupus is an unpredictable and potentially fatal autoimmune disease in which the immune system is out of balance, causing inflammation and tissue damage to any organ system in the body. The health effects of lupus include heart attacks, strokes, seizures, and organ failure. An estimated 1.5 million Americans and at least five million people worldwide have a form of lupus. For more information, visit www.lupus.org.
BENLYSTA was developed by Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) as an investigational therapy to treat lupus and last year successfully met its endpoints in two pivotal Phase III clinical trials.