Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) today announced positive results from BLISS-76, the second of two large-scale phase III clinical trials of BENLYSTA™ (belimumab) for treating systemic lupus. A full presentation of results from BLISS-52 was recently shared at the 73rd Annual Scientific meeting of the American College of Rheumatology. Both trials succeeded in meeting their primary endpoints, which should make BENLYSTA eligible for approval by the U.S. Food and Drug Administration (FDA).
Both trials demonstrate that treatment with BENLYSTA plus standard of care was superior to that of placebo (inactive agent) plus standard of care. BENLYSTA significantly reduced disease activity. If approved by the FDA, BENLYSTA would be the first drug ever developed and approved specifically for the treatment of lupus.
Sandra C. Raymond, President and Chief Executive Officer of the Lupus Foundation of America (LFA) issued the following statement.
“We are truly excited to receive this groundbreaking news! Individuals with lupus and their families have waited more than 50 years to hear that it is possible to develop therapies that control the disease. We believe that this is a significant first step in developing the full arsenal of therapies and personalized treatment lupus requires.
“Conducting clinical trials in lupus has been extremely difficult due to many factors including the heterogeneity of the disease, the selection of appropriate clinical trial endpoints, and the confounding role of required background medications given to clinical trial participants. Human Genome Sciences and GlaxoSmithKline have proven that these barriers, while formidable, can be overcome.
“For decades the entire lupus research community has worked hard to better understand the causes and consequences of the disease. The fruits of that labor are starting to emerge. However, now is not the time for complacency. We must band together for lupus and continue to capitalize on the decades of research made possible through the efforts of the many dedicated researchers, physicians, people with lupus, and advocates.
“This announcement by HGS and GSK and the Overcoming Barriers to Drug Development in Lupus report, commissioned by the Lupus Foundation of America to outline recommendations on ways to overcome the barriers to lupus research, combine to serve as a call to action for a national coordinated effort to accelerate the pace of discovery, to develop more tolerable and effective treatments, and to ultimately find a cure for this perilous disease.
“We congratulate HGS and GSK on reaching this important milestone in lupus research and in the development of new therapies for lupus. We also extend our appreciation to the researchers and study volunteers who made this achievement possible: the physicians who have passionately committed to researching this disease, and the companies that continue to invest in finding new and necessary treatments for this devastating disease.”
The next step in the process is for HGS and GSK to submit marketing applications in the United States, Europe and other regions during the first half of 2010. The LFA will closely follow this process, and continue to keep its constituents apprised of developments.
Lupus is an acute and chronic autoimmune disease in which the immune system is unbalanced, causing inflammation and tissue damage to virtually any organ in the body. Its health effects include heart attacks, strokes, seizures, miscarriages, and organ failure. Ninety percent of the people with lupus are women, and it is two to three times more common among African Americans, Hispanics/Latinos, Native Americans, and Asians. Lupus is unpredictable and potentially fatal.
Lupus Foundation of America