Tanzeum

Treatment for Diabetes Type 2

Update: Tanzeum (albiglutide) Now FDA Approved - April 15, 2014

BLA Submitted for Albiglutide

GSK Announces Submission of Albiglutide BLA to the US FDA for the Treatment of Type 2 Diabetes

GlaxoSmithKline (GSK) plc 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.

 

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:

David Mawdsley

+44 (0) 20 8047 5502

(London)

 

 

Sarah Spencer

+44 (0) 20 8047 5502

(London)

 

 

David Daley

+44 (0) 20 8047 5502

(London)

 

 

Catherine Hartley

+44 (0) 20 8047 5502

(London)

 

 

Alex Harrison

+44 (0) 20 8047 5502

(London)

 

 

 

 

 

 

US Media enquiries:

Stephen Rea

+1 215 751 4394

(Philadelphia)

 

 

Kevin Colgan

+1 919 483 2933

(North Carolina)

 

 

Melinda Stubbee

+1 919 483 2510

(North Carolina)

 

 

Mary Anne Rhyne

+1 919 483 0492

(North Carolina)

 

 

Sarah Alspach

+1 202 715 1048

(Washington, DC)

 

 

Jennifer Armstrong

+1 215 751 5664

(Philadelphia)

 

 

 

 

 

 

Analyst/Investor enquiries:

Sally Ferguson

+44 (0) 20 8047 5543

(London)

 

 

Lucy Budd

+44 (0) 20 8047 2248

(London)

 

 

Tom Curry

+ 1 215 751 5419

(Philadelphia)

 

 

Gary Davies

+ 44 (0) 20 8047 5503

(London)

 

 

James Dodwell

+ 44 (0) 20 8047 2406

(London)

 

 

Jeff McLaughlin

+ 1 215 751 7002

(Philadelphia)

 

 

Ziba Shamsi

+ 44 (0) 20 8047 3289

(London)

 

 

 

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.

 

 

Posted: January 2013

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