GSK sees PAH drug receive European positive opinion
22 February 2008 00:00 in Pharmaceutical Company Product News
GlaxoSmithKline (GSK) has seen Volibris (ambrisentan) receive a positive opinion from the European Committee for Human Medicinal Products (CHMP) for the treatment of patients with the class II and III pulmonary arterial hypertension (PAH).
The drug is expected to be granted approval by the European Commission and Marketing Authorisation in April 2008.
Study data shows Volibris to significantly improve exercise capacity as well as other parameters such as time to clinical worsening in PAH patients.
Nazzareno Galie, professor of cardiology and head of the Pulmonary Hypertension Centre at the University of Bologna, described Volibris' positive opinion as a "step forward" in the treatment of patients with PAH.
"Volibris has demonstrated efficacy in class II and III patients, with a low risk of drug-drug interactions and low incidence of liver function test abnormalities," he added.
GSK's president of Pharmaceuticals Europe, Eddie Gray, described the CHMP announcement as "excellent news" and that it demonstrated the company's continued commitment to the development of medicines for the treatment of PAH.
Earlier this month, GSK announced new price reductions to its antiretroviral range of products offered on a non-profit basis in the world's developing countries.
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