Refrigerator-Stable FluMist Submitted For Young Children
This article was originally published in The Pink Sheet Daily
Executive Summary
MedImmune submitted a supplemental BLA seeking use of refrigerator-stable intranasal flu vaccine FluMist to inoculate children ages 12 months to 59 months, the company announced July 31
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MedImmune submitted a supplemental BLA seeking use of refrigerator-stable intranasal flu vaccine FluMist to inoculate children ages 12 months to 59 months, the company announced July 31. During a recent earnings call, the company said it had revised its plan to request approval down to six months of age after examining data from a pivotal Phase III trial involving approximately 8,500 children between six months and 59 months (1 (Also see "MedImmune To Release Phase III Data By Year-End For Synagis Follow-On" - Pink Sheet, 21 Jul, 2006.)). MedImmune has said it anticipates approval of the refrigerator-stable formulation of FluMist in time for the 2007-2008 flu season. The firm recently received a "complete response" from FDA regarding use of the formulation to treat patients ages five to 49 years (2 (Also see "FluMist Refrigerator-Stable Formula On Track For 2007/2008 After FDA “Complete Response”" - Pink Sheet, 18 Jul, 2006.)). The company is gearing up to begin producing the new formula immediately upon approval, CEO David Mott said during the call. The company announced July 25 that it has begun shipping its current frozen, live attenuated FluMist for the coming season. |