FDA Approves GSK's Benlysta for Systemic Lupus Erythematosus

The U.S. Food and Drug Administration (FDA) has approved Benlysta (belimumab) for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy. GlaxoSmithKline (GSK) and Human Genome Sciences announced the approval on March 9, 2011.

Benlysta is the first new drug approved for the treatment of systemic lupus in more than five decades. The medication is expected to be available to physicians and patients by the end of March.

The drug's use is limited for patients without severe active lupus nephritis or severe central nervous system lupus. Its efficacy has not been evaluated in these patient groups and it has not been studied in combination with other biologics or intravenous cyclophosphamide.

Moncef Slaoui, Chairman of GSK Research and Development, emphasized that Benlysta's approval is an important step for appropriate lupus patients who have awaited new treatment options for managing their chronic condition. H. Thomas Watkins, President and CEO of Human Genome Sciences, stated that the companies are honored to bring Benlysta to the United States as the first new lupus drug in half a century.

Clinical trials reported more deaths in patients receiving Benlysta compared to placebo, and serious infections occurred slightly more frequently. Hypersensitivity reactions and psychiatric events, including depression and suicides, were also reported. The impact of the drug on the development of malignancies is unknown.