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Regulatory update - Benlysta® (belimumab)


London UK - GlaxoSmithKline PLC (GSK) announced today that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), for Benlysta (belimumab) for reducing disease activity in adult patients with autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standardtherapy. The submission was made in collaboration with Human Genome Sciences, Inc (HGS). Benlysta is being developed by GSK and HGS under a co-development and commercialisation agreement entered into in 2006.

HGS anticipates submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for belimumab, by the end of June 2010.

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

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