GlaxoSmithKline & Human Genome Sciences Benlysta Approved by FDA

Chairman of GSK Research and Development said, 'The approval of Benlysta is an important step for appropriate lupus patients.'

GlaxoSmithKline and Human Genome Sciences, Inc. announced that the U.S. FDA has approved Benlysta (belimumab) for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy.

The US label includes the following limitations of use: The efficacy of belimumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus, and has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of belimumab is therefore not recommended in these situations.

Moncef Slaoui, Ph.D., Chairman, GSK Research and Development, said, "The approval of Benlysta is an important step for appropriate lupus patients. Patients have been wa