US FDA requests more data on new formulation of MedImmune's FluMist

The US Food and Drug Administration has issued a Complete Response Letter for MedImmune's supplemental biologics license application related to the new formulation of FluMist (influenza virus vaccine live, intranasal) for the current approved indication. With the sBLA, MedImmune is seeking approval to use refrigerator-stable CAIV-T (cold adapted influenza vaccine, trivalent) in preventing influenza in healthy individuals five to 49 years of age and the agency is requesting clarification and additional information relating to data previously submitted. MedImmune plans to submit a separate sBLA, including Phase III data in 8,500 children between six months and 59 months of age, within the next few weeks, requesting an expanded label for the agent. The firm says it is on track with plans to launch the improved formulation of its intranasal influenza vaccine with an expanded indication down to one year of age in time for the 2007-2008 influenza season.