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GSK files Revolade in hepatitis C in Europe and US

Looks to expand the drug's chronic immune (idiopathic) thrombocytopenia licence

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".

1st June 2012

From: Sales



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