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GlaxoSmithKline receives approval in Japan for two medicines: Revolade and Xyzal

GlaxoSmithKline (GSK) announced that it has received approval in Japan from the Ministry of Health, Labour and Welfare for Revolade (eltrombopag) for the treatment of the blood disorder, chronic idiopathic thrombocytopenic purpura (ITP), and for Xyzal (levocetirizine dihydrochloride), the first new anti-histamine to be made available in Japan for eight years

Issued: London, UK

GlaxoSmithKline (GSK) announced that it has received approval in Japan from the Ministry of Health, Labour and Welfare for Revolade (eltrombopag) for the treatment of the blood disorder, chronic idiopathic thrombocytopenic purpura (ITP), and for Xyzal (levocetirizine dihydrochloride), the first new anti-histamine to be made available in Japan for eight years.

Revolade is the world’s first oral treatment that stimulates the production of blood platelets, which are essential to normal clotting. ITP patients experience bruising and bleeding and, in some cases, serious haemorrhages, which can be fatal. ITP may also affect a patient’s quality of life, as it is often associated with fatigue and depression and a fear of bleeding may limit everyday activities.

The anti-allergic drug, Xyzal, has been approved for the treatment of allergic rhinitis, urticaria, eczema and dermatitis, prurigo, and cutaneous pruritus in patients over the age of seven years.

Philippe Fauchet, President of GSK Japan, commented, “These approvals are very important to GSK as they demonstrate the progress we are making in gaining approvals in Japan for products that we believe can offer real value to patients. I believe this illustrates GSK’s commitment to actively developing treatments for diseases that affect broad groups of patients, such as allergic rhinitis, but also for rare and difficult to treat diseases, where only a small number of patients exist, such as ITP.

About eltrombopag

Eltrombopag was given accelerated approval by the US Food and Drug Administration (FDA) under the trade name Promacta® in November 2008, for the treatment of chronic ITP in adults who have had an insufficient response to corticosteroids, immunoglobulins or following surgical removal of the spleen. It was approved for use in Europe in March 2010 under the trade name Revolade as an oral treatment for thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP). Eltrombopag was discovered as a result of a research collaboration between GSK and Ligand Pharmaceuticals (NASDAQ: LGND), and developed by GSK.

About levocetirizine dihydrochloride

Levocetirizine dihydrochloride was developed by UCB and, since its approval in Germany in 2001, has been approved for the treatment of allergic diseases in over 90 countries worldwide including EU countries and the US. GSK acquired rights for the product in Japan and filed for approval in December 2008.

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

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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 'Business Review' in the company' s Annual Report on Form 20-F for 2009.