November 2010

Lupus Research Institute Highly Encouraged by FDA Advisory Committee’s Recommendation to Approve Benlysta for Lupus

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 today 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.

Historic Breakthrough

“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,” said Dowd.

“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,” said Dr. Schwartz.

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

Video: Margaret G. Dowd, Lupus Research Institute President and CEO, comments on the FDA Advisory Committee’s vote to recommend the approval of Benlysta for the treatment of lupus.






About the LRI
The world’s leading private supporter of innovative research in lupus, the LRI champions scientific risk-taking in the hunt for solutions to this complex and dangerous autoimmune disease.

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