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news.Novartis said the Committee for Medicinal Products for Human Use has recommended the EU approve Focetria, a human vaccine for use in pandemic influenza outbreak, such as one that could be caused by bird flu.
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Switzerland-based Novartis said the EU submission for Focetria was considered a “mock-up” since it lays the groundwork for a more rapid approval and availability of a specific vaccine once a pandemic has been declared.
Focetria would be manufactured to contain the pandemic influenza strain declared at the time of a pandemic along with the proprietary adjuvant MF59 developed by Novartis.
Dr Jorg Reinhardt, CEO of Novartis division vaccines and diagnostics, said: “This positive recommendation for our proprietary MF59-adjuvanted pandemic vaccine brings us one step closer to achieving public health and pandemic preparedness goals.”
In December 2006, GlaxoSmithKline’s Daronrix drug, a similar “mock up” vaccine for flu pandemics, was approved.