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EU and US Regulatory Update - Votrient® (pazopanib)

GlaxoSmithKline (GSK) announced today that it has submitted a variation to the Marketing Authorisation Application to the European Medicines Agency for Votrient (pazopanib) for the treatment of patients with advanced soft tissue sarcoma who have received prior chemotherapy, or for patients who are unsuited for such therapy.

Issued: London UK and Philadelphia, PA

GlaxoSmithKline (GSK) announced today that it has submitted a variation to the Marketing Authorisation Application to the European Medicines Agency for Votrient (pazopanib) for the treatment of patients with advanced soft tissue sarcoma who have received prior chemotherapy, or for patients who are unsuited for such therapy. 

Additionally, GSK announced that it has submitted a supplemental New Drug Application to the US Food and Drug Administration for Votrient for the treatment of patients with advanced soft tissue sarcoma who have received prior chemotherapy. 

The Phase III soft tissue sarcoma trial population excluded patients with adipocytic soft tissue sarcoma (liposarcoma) or gastrointestinal stromal tumour.

Votrient is not approved or licensed anywhere in the world for the treatment of advanced soft tissue sarcoma.  For more information about Votrient, including currently licensed indications, please visit www.gsk.com/products/prescription-medicines for EU Patient Information Leaflet and full US Prescribing Information including BOXED WARNING.

GlaxoSmithKline Enquiries:

   

UK Media enquiries:

David Mawdsley

(020) 8047 5502

 

Stephen Rea

(020) 8047 5502

 

Sarah Spencer

(020) 8047 5502

 

Janet Morgan

(020) 8047 5502

 

David Daley

(020) 8047 5502

 

 

 

US Media enquiries:

Nancy Pekarek

(919) 483 2839

 

Mary Anne Rhyne

(919) 483 2839

 

Kevin Colgan

(919) 483 2839

 

Sarah Alspach

(919) 483 2839

 

Robert Perry

(919) 483 2839

 

   

European Analyst/Investor enquiries:

Sally Ferguson

(020) 8047 5543

 

Gary Davies

(020) 8047 5503

 

Ziba Shamsi

(020) 8047 3289

 

Mark Elliot

(020) 8047 2617

     

US Analyst/ Investor enquiries:

Tom Curry

(215) 751 5419

 

Jeff McLaughlin

(215) 751 7002

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

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 2010.