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FDA Approves BENLYSTA® for Lupus in Breakthrough for Millions of Sufferers
Date:3/9/2011

urthermore, 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 www.LupusTrials.org.

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 Research Institute

The Lupus Res
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