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www.fdanews.com/articles/131938-fda-questions-safety-efficacy-of-benlysta-in-lupus

FDA Questions Safety, Efficacy of Benlysta in Lupus

November 15, 2010
The FDA is raising questions about Human Genome Sciences and GlaxoSmithKline’s lupus treatment Benlysta, saying the drug lacked efficacy in certain organ systems and populations and is associated with serious risks, including suicidality. Benlysta (belimumab) helped musculoskeletal and mucocutaneous organ systems; however, it did not show efficacy in organ systems associated with poor outcome and mortality in systemic lupus erythematosus patients, the FDA says in briefing documents for Tuesday’s meeting of the Arthritis Advisory Committee.
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