FDA APPROVES BENLYSTA® FOR LUPUS IN BREAKTHROUGH FOR MILLIONS OF SUFFERERS

Lupus Research Institute Welcomes First New Treatment Approved For Lupus in More Than 50 Years

Wednesday, March 9, 2011

The Lupus Research Institute (LRI) and its National Coalition of state and local lupus organizations welcome the U.S. Food and Drug Administration’s (FDA) historic approval of BENLYSTA® (belimumab) for systemic lupus erythematosus (lupus), launching the first safe and effective treatment for lupus in more than half a century.

“This is a moment of enormous relief for people with lupus, and a landmark achievement for the nation’s scientists, doctors and industry investigators searching for new answers to lupus,” said Margaret G. Dowd, president of the Lupus Research Institute, an organization uniquely dedicated to pioneering discovery through novel research in lupus. “Benlysta’s winding path to FDA approval is a triumph for the dedicated pursuit of innovative science and smart trial design in achieving solid results in the complex autoimmune disease of lupus.”

The FDA announced today 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.

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.

“With BENLYSTA, physicians can now prescribe an effective new agent to manage the signs and symptoms of lupus, and improve the quality of life of their patients,” said David S. Pisetsky, M.D., Ph.D., Professor of Medicine and Immunology at Duke University Medical Center and a member of the LRI Scientific Advisory Board.

"Furthermore, the approval provides important lessons for the lupus research field,” said Dr. Pisetsky. “The trial design of the BENLYSTA studies, including the use of a composite outcome measure to assess efficacy, is a major innovation. The developers have taken a new pathway for drug research in lupus, which hopefully, will encourage other companies to rededicate themselves to innovation to reduce and eventually wipe out the burden of this serious autoimmune disease.”

“The approval of BENLYSTA means good news for patients like me, hopefully reducing the seemingly endless number of medications with harsh side effects we need to take to stay alive,” said Sabrina Nixon, an author and single mother of two from Chicago who was diagnosed with lupus in 2004. "We thank the hundreds of people with lupus who enrolled and took part in these important BENLYSTA trials," said Dowd. The LRI assists in educating people with lupus about participating in clinical trials to bring safe and effective treatments to market. To learn more, visit http://www.LupusTrials.org.