LRI pleased with FDA Advisory Committee's approval of Benlysta for lupus

Lupus Research InstituteNov 17 2010

The Lupus Research Institute (LRI) and its National Coalition of state and local lupus organizations are pleased with the U.S. Food and Drug Administration (FDA) Advisory Committee's vote to recommend approval of Benlysta^® for active systemic lupus erythematosus (SLE), offering patients new found hope for the first approved treatment option in more than 50 years.

The U.S. FDA Arthritis Advisory Committee voted 13 to 2 to recommend approval of the treatment developed by Human Genome Sciences (HGS) and GlaxoSmithKline. The FDA will take the Advisory Committee's vote into consideration as it reviews Benlysta for approval. A decision by the FDA is expected to be announced by December 9, 2010.

"The panel's recommendation may signal the historic breakthrough that lupus patients have long awaited," said Margaret G. Dowd, president of the LRI, an organization uniquely dedicated to funding innovative approaches to lupus research. "This positive vote reinforces our community's resolve to increase the pace of scientific discovery and clinical development in lupus, made possible by the active participation of lupus patients in clinical trials."

"The results of both of Benlysta's phase III trials, BLISS-52 and BLISS-76, show that it reduces SLE disease activity, has a favorable safety profile and allows lupus patients to reduce their use of current treatment options that can cause serious adverse effects," said Benjamin Schwartz, M.D., Ph.D., a professor of clinical medicine at Washington University School of Medicine in St. Louis and a member of the LRI Scientific Advisory Board. "Benlysta would be a welcome addition to the limited number of treatments available for people with lupus."

"It's exhausting to be on such a tedious schedule of medicines which cause so many side effects," said lupus patient, Sabrina Nixon, "If approved, Benlysta will hopefully decrease the number of medications patients like me will need to stay alive."

Lupus is a perilous and chronic autoimmune disease that impacts an estimated 1.5 million Americans, primarily young women in their childbearing years. In lupus, the immune system attacks the body's own tissues and vital organs, making the illness a leading cause of premature cardiovascular disease, heart attack, stroke, and kidney disease among young women. Finding the cause, the cure and new treatments for lupus is a complex and challenging process.