AstraZeneca Canada Inc. announced today that it has filed a New Drug Submission (NDS) for FluMist(R) (Influenza Vaccine, Live Attenuated Intranasal) with Health Canada.
Working in partnership with its biologics subsidiary MedImmune, AstraZeneca Canada intends to bring MedImmune's leading vaccine technology to Canadian patients through its FluMist product, which is administered intranasally. The proposed indication for FluMist is for the prevention of seasonal influenza.
The submission is based on data from 73 global clinical and U.S. post-marketing studies of more than 141,000 subjects ranging in age from seven weeks to 97 years and conducted in 38 countries. During the 2004 to 2005 flu season, a large study was completed comparing FluMist, administered as a mist sprayed into the nose, to the injectable flu shot. The study included more than 8,000 children, of which more than 4,000 were between two to five years of age and showed that the group of children who received FluMist had significantly fewer cases of flu than the group who received the injectable flu shot.
"Every year, there is a significant medical and economic burden placed on the Canadian health care system due to vaccine-preventable illnesses. We are hopeful that our products may one day contribute to increased vaccination rates and reduce that burden of illness," said Dr. Catriona McMahon, Vice President, Medical Affairs. "As such, AstraZeneca Canada is pleased to submit its first application for a vaccine product in Canada."
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