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GSK Prepandrix given positive review by EMEA

Prepandrix, GlaxoSmithKline's new vaccination, was given a positive review by the European Committee for Medicinal Products for Human Use on February 21.

Prepandrix, GlaxoSmithKline's (GSK) new vaccination, was given a positive review by the European Committee for Medicinal Products for Human Use (CHMP) on February 21.

The European Medicines Agency (EMEA) has now recommended Prepandrix, which could prevent the spread of H5N1 avian influenza (bird flu), to the European Commission for marketing authorisation.

Jean Stephenne, president and general manager of GSK biologicals, said: "A number of national governments have expressed significant interest in stockpiling our candidate pre-pandemic H5N1 vaccine."

Authorisation of the vaccination has come at a critical time as World Health Organisation (WHO) figures show that since the initial outbreak of H5N1, 361 human cases of the disease have been recorded with 227 of those being fatal.

Prepandrix vaccines have been developed to trigger an immune response against avian influenza and could be used in the early stages of a major national or global outbreak.

The EMEA said: "Health authorities are concerned that the next pandemic could occur at some point within the next few years and could be caused by the H5N1 strain."

GSK also had another of its candidate drugs, Volibris, endorsed by CHMP and the EMEA, and expects final approval and marketing authorisation to be granted by the end of April 2008.

According to Professor Nazzareno Galie, professor of cardiology and head of the Pulmonary Hypertension Centre, Volibris (ambrisentan) represents a "step forward in the treatment of patients of pulmonary arterial hypertension (PAH)"

Eddie Gray, president of Pharmaceuticals Europe for GSK, said: "This positive opinion for Volibris is excellent news for patients of PAH across Europe."

22nd February 2008

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