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,

Benlysta is a trademark of Human Genome Sciences, Inc.