Regulatory update – BLA filed for Benlysta® (belimumab)

Issued: Thursday 10 June 2010, London UK GlaxoSmithKline PLC (GSK) announced today that Human Genome Sciences, Inc. (HGS) has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA), for Benlysta (belimumab) for reducing disease activity in adult patients with autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standardtherapy. Benlysta is being developed by GSK and HGS under a co-development and commercialisation agreement entered into in 2006. Belimumab is not approved or licensed anywhere in the world. 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, GlaxoSmithKline enquiries: UK Media enquiries: Philip Thomson (020) 8047 5502 Claire Brough (020) 8047 5502 Stephen Rea (020) 8047 5502 Alexandra Harrison (020) 8047 5502 Jo Revill (020) 8047 5502 US Media enquiries: Nancy Pekarek (919) 483 2839 Mary Anne Rhyne (919) 483 2839 Kevin Colgan (919) 483 2839 Sarah Alspach (919) 483 2839 European Analyst/Investor enquiries: David Mawdsley (020) 8047 5564 Sally Ferguson (020) 8047 5543 Gary Davies (020) 8047 5503 US Analyst/ Investor enquiries: Tom Curry (215) 751 5419 Jen Hill Baxter (215) 751 7002 Benlysta is a trademark of Human Genome Sciences, Inc.

The release as fetched from its publisher. gsk.com ↗