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GSK files Revolade (eltrombopag) in hepatitis C in Europe and US
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EASL 2012: Results of ENABLE-2, a Phase 3, Placebo-controlled, Multicenter Study of Eltrombopag, Peginterferon Alfa-2b, and Ribavirin Treatment in Patients with Hepatitis C and Thrombocytopenia - (05/23/12)
AASLD Nov 2011: Eltrombopag Therapy for HCV-Related Thrombocytopenia: Final Results of ENABLE 1, a Phase 3, Multicenter Study of Eltrombopag as an Adjunct for Antiviral Treatment of Hepatitis C Virus-Related Chronic Liver Disease Associated with Thrombocytopenia - (12/12/11)
pmlive.com
GlaxoSmithKline (GSK) has filed for approval of Revolade (eltombopag) in Europe and the US as a treatment for low blood platelet counts in patients with chronic hepatitis C virus infection.
Revolade was first licensed in Europe in 2010 for blood disorder chronic immune (idiopathic) thrombocytopenia, or ITP, and the pharma company has submitted a variation to the Marketing Authorisation Application.
This would allow Revolade to be used as a treatment for thrombocytopenia in adult patients with chronic hepatitis C infection to enable the initiation of interferon-based therapy and during interferon-based therapy.
Treatment with interferon can sometimes reduce platelet levels, and patients with this complication can be excluded from starting or being maintained on treatment, leading to quicker progression of the illness.
If approved in the US the drug would be marketed there as Promacta. Last year its ITP indication brought in 75m ($116m) in sales, and analysts have previously predicted the sheer scale of the hepatitis C virus market could dramatically increase the drug's earnings potential.
Some peak annual sales estimates have suggested it has the potential to rise as high as $2bn given that around 180m people around the world are chronically infected with the hepatitis C virus.
An earlier decision to terminate a trial of the drug in chronic liver disease as a result of a clotting risk has dented some of that optimism, but GSK said recently it planned to start a new phase III trial in that indication, as well as an oncology-related phase III trial that could provide another future indication.
GSK's partner for the drug - Ligand Pharmaceuticals - recently reaffirmed its confidence that blockbuster sales were in the offing given sales momentum and "potential for major label expansion".
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Regulatory Update Ð GSK announces submissions in the EU & US for new indications for Promacta®/Revolade®
Issued: Wednesday 30 May 2012, London UK press announcement
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.
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