Aviron has announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for FluMist(TM), an investigational intranasal influenza vaccine.
On October 31, 2000, Aviron submitted a BLA to the FDA seeking U.S.
licensure of FluMist(TM) to prevent influenza in healthy children and healthy
adults. Friday's decision by the FDA to accept the submission for review was
the next step in the regulatory process. If approved, FluMist(TM) would be
the first flu vaccine delivered as a nasal mist to be commercially available
in the US.
The BLA acceptance triggers a $15.5 million payment to Aviron from
American Home Products Corporation as part of an ongoing global
collaboration agreement for the development and marketing of FluMist(TM).
Annual influenza epidemics in the United States typically affect 10 to
20 percent of the general population and cause approximately 20,000 deaths.
FluMist(TM), which is delivered as a nasal mist, could be an important new way
to protect people from the flu. FluMist(TM) may be particularly significant
for children, who suffer high influenza attack rates and are thought to be
important in the spread of influenza.
Aviron is a biopharmaceutical company based in Mountain View, California, focused on the prevention of disease through innovative vaccine technology. For more information, visit Aviron Influenza Overview - Recent Results.