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Promise of a New Lupus Treatment Is a Groundbreaking Achievement
Date:11/2/2009

BENLYSTA(TM) Successful in Second Pivotal Clinical Trial

WASHINGTON, Nov. 2 /PRNewswire-USNewswire/ -- Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) today announced positive results from BLISS-76, the second of two large-scale phase III clinical trials of BENLYSTA(TM) (belimumab) for treating systemic lupus. A full presentation of results from BLISS-52 was recently shared at the 73rd Annual Scientific meeting of the American College of Rheumatology. Both trials succeeded in meeting their primary endpoints, which should make BENLYSTA eligible for approval by the U.S. Food and Drug Administration (FDA).

Both trials demonstrate that treatment with BENLYSTA plus standard of care was superior to that of placebo (inactive agent) plus standard of care. BENLYSTA significantly reduced disease activity. If approved by the FDA, BENLYSTA would be the first drug ever developed and approved specifically for the treatment of lupus.

Sandra C. Raymond, President and Chief Executive Officer of the Lupus Foundation of America (LFA) issued the following statement.

"We are truly excited to receive this groundbreaking news! Individuals with lupus and their families have waited more than 50 years to hear that it is possible to develop therapies that control the disease. We believe that this is a significant first step in developing the full arsenal of therapies and personalized treatment lupus requires.

"Conducting clinical trials in lupus has been extremely difficult due to many factors including the heterogeneity of the disease, the selection of appropriate clinical trial endpoints, and the confounding role of required background medications given to clinical trial participants. Human Genome Sciences and GlaxoSmithKline have proven that these barriers, while formidable, can be overcome.

"For decades the entire lupus research community has worked hard to better understand the causes and conseq
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SOURCE Lupus Foundation of America
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