MedImmune to expand flu drug application

Drug maker MedImmune Inc. said it will use new research data to expand an application on file with the Food and Drug Administration for its next-generation inhalable flu vaccine to include children as young as 6 months old. The company released data from a late-stage clinical trial showing that the CAIV-T vaccine lowered the risk of flu in children aged 6 months to 59 months by 55 percent compared with a traditional injected vaccine. The study, which enrolled 8,475 children, showed 3.9 percent of children given CAIV-T developed the flu compared with the 8.6 percent of vaccinated children who developed flu. CAIV-T is the next generation of MedImmune's FluMist vaccine. Whereas FluMist must be stored in a freezer, CAIV-T can be stored in a refrigerator. In September, the company filed an application with the FDA for CAIV-T to treat patients from 5 years old to 49 years old. MedImmune hopes to file a supplemental application to extend that to patients as young as 6 months old by June. "Source":[http://www.businessweek.com/ap/financialnews/D8HB1GKO1.htm?campaign_id=apn_home_do].

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