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news.The US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target date for its priority review of Human Genome Sciences (HGS) and GlaxoSmithKline's (GSK) biologics license application (BLA) for Benlysta (belimumab) as a potential treatment for systemic lupus erythematosus (SLE) from 9 December 2010 to 10 March 2011.
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Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors.
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.
HGS and GSK are developing Belimumab under a definitive co-development and co-commercialization agreement entered into in 2006.