Lupus Drug Nears FDA Approval

An FDA advisory committee has recommended approval for Benlysta, a monoclonal antibody to treat lupus being developed by Human Genome Sciences and GlaxoSmithKline. If approved, Benlysta would be the first new drug in decades to treat lupus, a chronic disease that occurs when immune system antibodies attack healthy tissues. It would also be Human Genome’s first marketed product. Benlysta works by blocking B-lymphocyte stimulator, a protein that is overexpressed in lupus and other autoimmune diseases. FDA does not always follow the advice of its advisory committee, although the vote of 13 to 2 for approval suggests chances are good for Benlysta. FDA will make its final decision on the drug by Dec. 9.