Human Genome Sciences Inc. (HGSI) and GlaxoSmithKline Plc (GSK, GSK.L) said that the U.S. FDA has extended the target date to approve its Benlysta as a potential treatment for systemic lupus erythematosus (SLE).
The target date has now been extended to March 10, 2011 from December 9, 2010.
After the FDA Arthritis Advisory Committee met on November 16, to consider the Biologics License Application of Benlysta, 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.
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