GSK Regulatory Update: Avodart

GlaxoSmithKline (GSK) announced today that in order to provide an update to the application, the company is withdrawing its US Supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for prostate cancer risk reduction among men at increased risk of developing the disease. GSK expects to resubmit the file shortly. This action is not the result of new findings related to safety or efficacy

Issued: Monday 23 November, London UK

GlaxoSmithKline (GSK) announced today that in order to provide an update to the application, the company is withdrawing its US Supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for prostate cancer risk reduction among men at increased risk of developing the disease.  GSK expects to resubmit the file shortly.  This action is not the result of new findings related to safety or efficacy.

Review of the EU filings will begin once the same update has been provided to the EU regulatory agencies.

Dutasteride is not approved or licensed in the US or Europe to treat or reduce the risk of prostate cancer.  For more information about Avodart, please see the full prescribing information at www.gsk.com.

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:

Philip Thomson

(020) 8047 5502

 

Claire Brough

(020) 8047 5502

 

Stephen Rea

(020) 8047 5502

 

Alexandra Harrison

(020) 8047 5502

 

Gwenan White

(020) 8047 5502

 

 

 

US Media enquiries:

Mary Anne Rhyne

(919) 483 2839

 

Kevin Colgan

(919) 483 2839

 

Sarah Alspach

(919) 483 2839

 

European Analyst/Investor enquiries:

David Mawdsley

(020) 8047 5564

Sally Ferguson

(020) 8047 5543

Gary Davies

(020) 8047 5503

US Analyst/ Investor enquiries:

Tom Curry

(215) 751 5419

Jen Hill Baxter

(215) 751 7002

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 'Business Review' in the company' s Annual Report on Form 20-F for 2008.