March 10, 2011 --The Lupus Alliance of America, a member of the Lupus Research Institute (LRI) National Coalition, welcomes the U.S. Food and Drug Administration's (FDA) historic approval of BENLYSTA ® (belimumab) for systemic lupus erythematosus (lupus), which is the first new treatment for the chronic autoimmune disease in more than half a century.
On Wednesday, The FDA announced 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.
JoAnn Quinn, Executive Director of the Lupus Alliance of America, LIQ Affiliate said, "On behalf of the LAA LIQ and all of those who live with lupus that we serve every day, we wish to thank the physicians, researchers, those at Human Genome Sciences and GlaxoSmithKline, and most importantly the study volunteers who made this moment possible. Speaking as someone who has lived with lupus for over 40 years, this moment was deeply emotional. As both a patient and someone who has fought as an advocate to help all of us who live with this debilitating disease on a daily basis, this day has been a long time coming, and fills me and all of us in the lupus community with hope that we are finally getting the notice and help we all deserve. "
The development of BENLYSTA stems from the scientific discovery of a new immune system molecule, BLyS, which revealed a critical new pathway that can be manipulated to treat lupus. Benlysta is founded on novel, fundamental science from industry and academia that explores a range of disease pathways and mechanisms, much like the studies that the LRI has been supporting for a decade.
Honi Kurzeja, President of the Lupus Alliance of America, issued the following statement regarding this landmark decision: "This is a day everyone who has lupus has waited 56 years to see. It is a day that we at the Alliance have waited and fought through many years of blood, sweat and tears to finally see a new drug specifically approved to treat lupus. Over the years that we have served those who live with this devastating disease; held their hands, listened to their stories, and shared their tears, we have wanted nothing more than to find a way to ease their pain. Benlysta is the first significant step towards that goal, and a milestone in our ultimate goal of developing new, safe, and effective treatment for the disease."
Dr. Richard Furie, Board member of the Lupus Alliance of America LIQ Affiliate and Chief, Division of Rheumatology and Allergy-Clinical Immunology, North Shore-LIJ Health System said the following, "The FDA has kept the lupus community on the edge of our seats since the FDA Arthritis Advisory Committee meeting in November 2010 when the committee voted 13-2 in favor of approving Benlysta. However 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. 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."
Dr. Furie continued explaining how Benlysta works, "Benlysta works by starving certain types of white blood cells (known as B lymphocytes or B cells) of a required growth factor. Specifically, Benlysta is an engineered antibody that reacts with BLyS, B lymphocyte stimulator, a protein found in higher levels in patients with active lupus. By reducing the activity of B cells, Benlysta reduces lupus disease activity."
"While each physician may have a different threshold for initiating treatment with Benlysta, in general it is indicated for patients with active disease despite conventional background therapy. The drug takes time to work. In fact, in the US study, it wasn't until one year that a statistical difference was seen between placebo and drug. However, there were many other clues (laboratory tests, reduction in disease activity) that the drug started working far earlier. It is given by intravenous infusion over one hour; therefore, start-to-finish will most likely approach one and one-half hours. After the first three infusions, which are spaced at two week intervals, the drug is given every 4 weeks."
About Lupus:
Lupus-systemic lupus erythematosus-is a chronic and often disabling autoimmune disease that is estimated to affect more than 1.5 million Americans. Ninety percent of people living with lupus are women, with the majority being of childbearing age. People with lupus suffer from symptoms including fever, intense fatigue and exhaustion, joint pains, cognitive problems and skin rashes. No two cases of lupus are alike, and the effects of the disease can range from kidney disease, premature heart disease, stroke or lung inflammation. There is no known cause or cure for lupus, and no new treatments have been approved for lupus in over 50 years. For some patients, current treatments can often be toxic and more damaging than the disease itself.
About The Lupus Alliance of America LIQ Affiliate.
The Lupus Alliance of America LIQ Affiliate was founded in the kitchens of dedicated volunteers in 1955 with the express purpose of providing needed services to those affected by lupus within their local communities. Our Mission is to provide support and education to better the quality of life for people with lupus and their families, to promote awareness and understanding of lupus to others and to support research that will improve the diagnosis and treatment of lupus and ultimately discover its cause and cure. This support includes providing money for such research and the dissemination of information that will help to advance those efforts.