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AstraZeneca receives positive CHMP opinion on Fluenz
AstraZeneca has been granted a recommendation from a European Medicines Agency committee on Fluenz, a nasal spray vaccine for seasonal influenza.
The Committee for Medicinal Products for Human Use (CHMP) has endorsed approval of the company's marketing authorisation application for the treatment to be used among children aged between 24 months and 18 years of age.
It reached its decision following a review of positive data from 73 clinical trials and post-marketing studies, involving more than 141,000 subjects in 38 countries.
The European Commission will now decide on a final ruling and is expected to announce its decision within a few months.
Dr Alex Zukiwski, executive vice-president and chief medical officer for AstraZeneca's biologics unit MedImmune, said: "We are hopeful that the future availability and product characteristics of this novel nasal spray influenza vaccine will reduce the spread of influenza around the globe."
Earlier this month, the company published a clinical study highlighting the efficacy of Iressa, a new treatment option for non-small cell lung cancer.
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