NEW YORK, July 21, 2017 /PRNewswire-USNewswire/ -- The Lupus Research Alliance congratulates GlaxoSmithKline (GSK) on the approval of belimumab (Benlysta®) by the U.S. Food and Drug Administration as a self-injectable (subcutaneous) formulation for people with systemic lupus erythematosus (SLE) being treated with standard therapy.
Belimumab is currently approved as a one-hour intravenous infusion given once every four weeks by a healthcare professional in a hospital or clinic. The new formulation allows patients to administer the drug to themselves as a once-weekly injection.
Lupus Research Alliance CEO and President Kenneth M. Farber, commented, "The new self-injectable belimumab may improve quality of life for many people with lupus. For people living with a disease that too often necessitates multiple medications and numerous regular doctor's visits, the convenience and independence offered by being able to take one treatment in the privacy and comfort of your own home can mean a great deal."
The approval is based on data from a large controlled study of more than 800 patients with active SLE, which measured reduction in disease activity at Week 52 in patients receiving belimumab plus standard of care, versus those receiving placebo plus standard of care (assessed by SRI, a composite measure of efficacy in lupus).
GSK anticipates that the new formulation will be available in specialty pharmacies late August 2017.
Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. More than 90% of lupus sufferers are women, mostly young women between the ages of 15 to 44. Women of color are especially at risk. In lupus, the immune system, which is designed to protect against infection, creates antibodies that attack the body's own tissues and organs -- the kidneys, brain, heart, lungs, blood, skin, and joints.
About Lupus Research Alliance
The Lupus Research Alliance unites the global lupus community in bold determination to free the world of lupus through the power of science. We will transform the lives of people affected by lupus as we welcome and embrace a new scientific era, pioneer innovation, push the frontiers of knowledge, enlist diverse new scientific talent, and lead the drive to new treatments, prevention and cure. Because the Lupus Research Alliance Board of Directors funds all administrative and fundraising costs, 100% of all donations goes to support lupus research programs.
SOURCE Lupus Research Alliance