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Regulatory Update – GSK announces submissions in the EU & US for new indications for Promacta®/Revolade®


Issued: Wednesday 30 May 2012, London UK

GlaxoSmithKline plc announced today that it has submitted regulatory applications in the European Union and United States related to eltrombopag (Promacta®/Revolade® ) and its use to increase platelet counts in patients with chronic hepatitis C virus infection and low platelets (thrombocytopenia), specifically,

a variation to the Marketing Authorisation Application to the European Medicines Agency for Revolade (eltrombopag) as a treatment for thrombocytopenia in adult patients with chronic hepatitis C infection to enable the initiation of interferon-based therapy and during interferonbased therapy. a supplemental New Drug Application to the US Food and Drug Administration for Promacta (eltrombopag) as a treatment for thrombocytopenia in adult patients with chronic hepatitis C infection to enable the initiation of interferon-based therapy and to optimise interferonbased therapy.

About eltrombopag (Promacta®/Revolade®) Eltrombopag, known by the brand name Promacta in the United States and Revolade in the European Union and other countries, is currently approved in 88 countries around the world as a treatment for thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia.

Important Safety Information Promacta may cause hepatotoxicity. Other risks for Promacta include: bone marrow reticulinformation and risk for bone marrow fibrosis, thrombotic/thromboembolic complications, hematologic malignancies, and cataracts.

For more important safety information about the currently licensed indications forPROMACTA/Revolade, please visit Revolade - Prescription medicines - Our products -GlaxoSmithKline to view the Revolade EU Patient Information Leaflet and visit Promacta - Prescription medicines - Our products - GlaxoSmithKline for full Promacta US Prescribing Information including BOXED WARNING risk for hepatotoxicity.

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