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Ligand/GSK's Promacta cleared for hep C in US

New FDA approval is expected to open up a significant new market for the drug

GSK GlaxoSmithKline house 

Sales of GlaxoSmithKline and Ligand Pharmaceuticals' platelet-boosting drug Promacta look set to expand after it was approved in the US for use in patients with hepatitis C.

Promacta (eltrombopag) is already marketed for the treatment of low blood platelet counts in patients with the autoimmune disease idiopathic thrombocytopenic purpura (ITP), but use in hepatitis C is expected to open up a significant new market for the drug.

Approximately 4.2 million people in the US have chronic hepatitis C, and around 3.5 per cent of these have low platelet counts which can prevent them from starting or maintaining therapy for the infection.

"Promacta is the first supportive care treatment available to patients who are ineligible or poor candidates for interferon-based therapy due to their low blood platelet counts," said GSK in a statement.

In trials, treatment with Promacta boosted sustained virologic response (SVR) rates with an interferon alfa-based treatment regimen to 19-23 per cent, compared to 13-14 per cent with placebo.

Promacta - which is sold as Revolade in Europe and other markets outside the US - has been growing nicely since its launch in 2011, with GSK recently reporting sales up almost 60 per cent in the third quarter to $55m, and Ligand pocketing $2.2m in royalties.

Analysts have suggested Promacta sales have the potential to rise as high as $2bn a year at peak, given that around 180m people around the world are chronically infected with the hepatitis C virus and the drug is also in around 30 trials for other indications.

GSK and Ligand are also exploring the use of Promacta in other indications such as low blood platelet counts associated with cancer, with some data due for presentation at the American Society of Haematology (ASH) meeting in December.

GSK noted that Promacta has been approved with a boxed warning pointing to a risk of hepatotoxicity and hepatic decompensation, and cautioned that the drug should not be used to normalise platelet counts.

It also stressed that the safety and efficacy of the drug in combination with direct-acting antiviral agents for hepatitis C - such as Merck & Co's Victrelis (boceprevir) and Vertex Pharma's Incivo (telaprevir) - has not been established.

GSK filed the drug, as Revolade, for European approval in hepatitis C in June. 

20th November 2012

From: Sales

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