Regulatory Update – GSK announces submissions in the EU & US for new indications for Promacta®/Revolade®
GSK announced today that it has submitted regulatory applications in the EU and US related to eltrombopag (Promacta®/Revolade® ) and its use to increase platelet counts in patients with chronic hepatitis C virus infection and low platelets.
Issued: 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 for PROMACTA/Revolade, please visit the Products section of this website to view the Revolade EU Patient Information Leaflet and visit the Products section of us.gsk.com 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
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GlaxoSmithKline 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 'Financial review & risk' section in the company's Annual Report 2011 included as exhibit 15.2 to the company's Annual Report on Form 20-F for 2011.
