Revolade gets European go ahead
pharmafile | March 15, 2010 | News story | Sales and Marketing | GlaxoSmithKline, Revolade, thrombocytopenia
European regulators have approved GlaxoSmithKline’s Revolade to treat reduced platelet count in patients with a rare blood disorder.
Revolade (eltrombopag) have been licensed as an oral treatment for thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune thrombocytopenic purpura (ITP).
The drug is indicated for ITP patients who have not responded to other treatments, such as corticosteroids and immunoglobulins.
It is marketed as Promacta in the US, where the FDA approved it in November 2008 to treat thrombocytopenia patients suffering from ITP.
The drug was discovered as part of a research collaboration between GSK and biotech company Ligand Pharma.
Ligand’s chief executive John Higgins said: “The marketing authorisation from the EC of Revolade highlights Ligand’s success in entering pharmaceutical relationships that ultimately result in market approval.
“Revolade represents a significant treatment option available for ITP patients and the European approval expands the commercial potential for the drug.”
Chronic ITP is a disorder characterised by low levels of platelets in the blood, with patients suffering from excessive bruising and bleeding and in some cases having serious haemorrhages that can be fatal.
There are estimated to be approximately 60,000 individuals diagnosed with chronic ITP in the US and a similar figure in EU.
Although ITP can be managed, it is still associated with significant mortality and morbidity. The predicted five-year mortality is between 2% for young patients and 48% for older patients.
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