Novartis' Focetria gets nod from CHMP

Swiss drug major Novartis has received a positive opinion supporting European Union regulatory approval of its human vaccine Focetria for use in the event of a pandemic influenza outbreak, such as one that could be caused by the H5N1 strain of the avian influenza virus. The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of this new vaccine, and the European Commission generally follows its recommendations, delivering a final decision within two to three months.

The EU submission for Focetria lays the groundwork for a more rapid approval and availability of a specific vaccine once a pandemic has been declared. The agent 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. Studies have shown that MF59 could boost the body's immune response to the vaccine's active constituent and extend vaccine supplies by allowing for smaller amounts of viral antigens to be used in each dose compared to vaccines without this additive.