(Washington, DC) Today, the U.S. Food and Drug Administration (FDA) issued an announcement that a final decision on BENLYSTA for the treatment of the autoimmune disease lupus has been delayed until March 10, 2011. At a public hearing held on November 16, 2010, the FDA Arthritis Advisory Committee voted to recommend BENLYSTA for approval.
Sandra C. Raymond, President and Chief Executive Officer of the Lupus Foundation of America (LFA) has issued the following statement regarding the FDA’s announcement:
“It is important to understand that a delayed decision from the FDA does not indicate if they will approve or reject BENLYSTA. We appreciate the efforts of the FDA to ensure that medications for people with lupus are safe, effective, and tolerable. The LFA eagerly awaits the final decision from the FDA, and will continue to follow this process closely.”
About the LFA
The Lupus Foundation of America 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 in November the FDA Arthritis Advisory Committee voted to recommend BENLYSTA for approval.