Regulatory Update – GSK Announces Regulatory Submission for Albiglutide in Europe
London UK – LSE Announcement -GlaxoSmithKline plc (GSK) today announced the submission of a Marketing Authorisation Application (MAA) for albiglutide, with the proprietary name EPERZAN™, to the European Medicines Agency (EMA). Albiglutide is an investigational once-weekly treatment for adult patients with type 2 diabetes which is not yet approved anywhere in the world. On 14th January 2013, GSK announced the submission of a regulatory application in the United States for 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.
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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.
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