Advisory-panel meetings are always great windows into the mind of the FDA. Influenza vaccine FluMist, from MedImmune
The advisory panel debated several issues related to FluMist. It voted that the safety and efficacy data supported the drug's use in children as young as 2 years old, but not younger. This is important because FluMist's biggest advantage is its dosing via nasal spray rather than injection, but the largest population that would prefer a spray flu vaccine -- children younger than age f5 -- are not all yet approved to use the drug.
With the unanimously positive advisory panel vote in favor of the drug's efficacy and safety for most of this patient group, FluMist should gain regulatory approval, and thus an expanded label, in this patient population later this month. Keep in mind, though, that advisory panel votes are non-binding.
FluMist has been something of a flop for MedImmune since its marketing approval in 2003, with sales of only $36 million last year, up 71% versus 2005. The drug is relatively expensive compared to other options from companies like GlaxoSmithKline
Getting this improved label for FluMist doesn't nearly justify the $15 billion purchase price that AstraZeneca
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