Human Genome Sciences and GlaxoSmithKline have been granted a priority review designation for Benlysta (belimumab) as a potential treatment for systemic lupus erythematosus (SLE). The FDA has assigned belimumab a Prescription Drug User Fee Act (PDUFA) target date of December 9, 2010. The BLA for belimumab was submitted to the FDA on June 9, 2010, and includes the results of two Phase III trials that treated a total of 1,684 autoantibody-positive patients with SLE. HGS designed the Phase III p...