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EC green lights Volibris

GlaxoSmithKline has revealed that the European Commission has granted marketing authorisation for Volibris, which can now be prescribed across the EU market
GlaxoSmithKline (GSK) has revealed that the European Commission has granted marketing authorisation for Volibris, which can now be prescribed across the EU market.

Volibris (ambrisentan) has been developed to treat patients with pulmonary arterial hypertension (PAH). It is hoped that it will improve the exercise capacity of sufferers classified as functional class II and III by the World Health Organisation (WHO).

Nazzareno Galie, professor of cardiology and head of the Pulmonary Hypertension Centre at the University of Bologna, said: "Ambrisentan represents a development in the treatment of patients with PAH. It has demonstrated efficacy and safety in both functional class II and III patients. New treatments like this are important and make incremental improvements to patients' quality of life."

Patients diagnosed with PAH have an average life expectancy of 2.8 years, a figure that recent data indicates could be rising due to advances in diagnosis and treatment. The disease affects over 200,000 people globally and is a rare and fatal disorder causing complications of the arteries and lungs.

Professor Ardeschir Ghofrani, head of the pulmonary hypertension division at the University Hospital Giessen, Germany, said: "Ambrisentan's low risk of drug-drug interactions and low incidence of liver function test abnormalities offer important additional benefits to patients with PAH whose quality of life is already significantly compromised by this progressive life-threatening condition."

GSK plans to launch ambrisentan in Europe sometime during the summer of 2008.

28th April 2008

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