Tanzeum

Treatment for Diabetes Type 2

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

Regulatory Update: Albiglutide US PDUFA Date Extended by Three Months

Issued: Friday 2 August 2013, London UK

GlaxoSmithKline plc (LSE:GSK) today announced that the US Prescription Drug User Fee Act (PDUFA) goal date for albiglutide, an investigational once-weekly treatment for adult patients with type 2 diabetes, has been extended by three months to 15 April 2014 to provide time for a full review of information submitted by GSK in response to the Food and Drug Administration’s requests.

GSK announced the submission of a Biologics Licence Application to the US FDA for albiglutide on 14 January 2013 and this was followed by the submission of a Marketing Authorisation Application to the European Medicines Agency (EMA) on 7 March 2013. The EMA filing is progressing to schedule. Albiglutide is not approved for use anywhere in the world.

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)

Simon Steel

+44 (0) 20 8047 5502

(London)

David Daley

+44 (0) 20 8047 5502

(London)

Catherine Hartley

+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:

Ziba Shamsi

+ 44 (0) 20 8047 3289

(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)

Cautionary statement regarding forward-looking statements
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 Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.

Posted: August 2013

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Tanzeum (albiglutide) FDA Approval History

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