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news.The US Food and Drug Administration (FDA) has approved Human Genome Sciences (HGS) and GlaxoSmithKline’s (GSK) BENLYSTA (belimumab) to treat adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy.
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Belimumab, the first in a new class of drugs called BLyS-specific inhibitors, blocks the binding of soluble BLyS, a B-cell survival factor, to its receptors on B cells.
HGS and GSK are developing BENLYSTA under a definitive co-development and co-commercialization agreement entered into in 2006.
GSK submitted a Marketing Authorization Application (MAA) for BENLYSTA to the European Medicines Agency (EMA) in June 2010.
Regulatory applications have also been submitted and are currently under consideration in Canada, Australia, Switzerland, Russia, Brazil and The Philippines.
HGS president and CEO H Thomas Watkins said they expect to have this novel therapy available to physicians and patients within about two weeks, and their entire organization looks forward to the positive impact they hope this new therapy will have for patients with systemic lupus.