GSK submits albiglutide BLA to the US FDA

RNS Number : 4577V

GlaxoSmithKline PLC

14 January 2013

Issued: Monday 14 January 2013, London UK - LSE Announcement

Regulatory update - GSK announces submission of albiglutide BLA to the US FDA for the treatment of type 2 diabetes

GlaxoSmithKline plc (LSE: GSK) today announced a regulatory submission to the US Food and Drug Administration (US FDA) for albiglutide, an investigational once-weekly treatment for adult patients with type 2 diabetes. Albiglutide is not yet approved as a treatment for type 2 diabetes or any other indication anywhere in the world. GSK intends to submit a regulatory application in the European Union (EU) in early 2013.

About albiglutide

Albiglutide, a GLP-1 receptor agonist, is an investigational biological product for the treatment of type 2 diabetes designed for once-weekly subcutaneous dosing. GLP-1 is a peptide that is normally secreted from the gastrointestinal tract during a meal which in turn helps release insulin to control blood sugar elevations after eating. In people with type 2 diabetes, GLP-1 secretion in response to a meal is reduced or absent. GLP-1 is rapidly degraded while albiglutide has been developed to have a longer duration of action by being comprised of two copies of modified human GLP-1 fused in series to human albumin.

V A Whyte

Company Secretary

14 January 2013

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Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk factors' in the 'Financial review & risk' section in the company's Annual Report 2011 included as exhibit 15.2 to the company's Annual Report on Form 20-F for 2011.