GlaxoSmithKline and Human Genome Sciences announce FDA extension of Benlysta
GlaxoSmithKline PLC (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) 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 9 th December 2010 to 10 th March 2011. After the FDA Arthritis Advisory Committee met on 16 November 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.
December 08, 2010