FDA extends PDUFA review target date for BENLYSTA BLA to treat systemic lupus erythematosus

Dec 4 2010

Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (GSK) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target date for its priority review of the Biologics License Application (BLA) for BENLYSTA® (belimumab) as a potential treatment for systemic lupus erythematosus (SLE) from December 9, 2010 to March 10, 2011.

After the FDA Arthritis Advisory Committee met on November 16, 2010 to consider the BENLYSTA BLA, the FDA requested some additional information from HGS, which has been submitted.

Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. HGS and GSK are developing belimumab under a definitive co-development and co-commercialization agreement entered into in 2006.