Boost for Aviron as FluMist clears hurdle

2 January 2001

Aviron's chances of securing US approval for its intranasal influenzevaccine FluMist were raised a peg at the end of last year, after the Food and Drug Administration accepted the firm's Biologics License Application for review.

On October 31, Aviron submitted its BLA seeking approval of FluMist in the prevention of influenza in healthy children and healthy adults. The company had originally planned to file for approval in 1999, with a view to gaining clearance in time for the 2000-2001 flu season, but had been held back by agency requests for more information to bolster the dossier (Marketletters passim). If approved, FluMist would be the first intranasal flu vaccine to be available in the USA.

The BLA acceptance triggers a $15.5 million payment to Aviron from American Home Products as part of an ongoing global collaboration agreement for the development and marketing of the vaccine.

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