GSK reports U.S. approval of Benlysta for intravenous use in children with lupus

GlaxoSmithKline announced that the U.S. Food and Drug Administration has approved, under priority review, the use of the intravenous formulation of Benlysta, a B-lymphocyte stimulator-specific inhibitor, in children with lupus from as young as five years of age. The approval extends the current indication in the US for the IV formulation of Benlysta in adults, to patients aged 5 years and older with active, autoantibody-positive, systemic lupus erythematosus who are receiving standard therapy. Benlysta was approved in the U.S. in March 2011 for adults, and is currently the only medicine specifically approved in the US for both adults and children with SLE, the company said.

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