GlaxoSmithKline and Human Genome Sciences announce FDA extension of Benlysta® PDUFA target date to 10th March 2011
Issued: Friday 3 December 2010
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 9th December 2010 to 10th 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.
About GlaxoSmithKline
GSK Biopharm R&D is employing novel approaches to harness the therapeutic potential of biopharmaceuticals for the benefit of patients with serious autoimmune disease.
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com
About Human Genome Sciences
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs.
For more information about HGS, please visit the Company’s web site at www.hgsi.com. Health professionals and patients interested in clinical trials of HGS products may inquire via e-mail to medinfo@hgsi.com or by calling HGS at (877) 822-8472.
HGS, Human Genome Sciences, and Benlysta are trademarks of Human Genome Sciences, Inc. Other trademarks referenced are the property of their respective owners.
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