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FDA Advisory Committee Recommends Expanded Use of FluMist

Influenza :: FDA Advisory Committee Recommends Expanded Use of FluMist

MedImmune, Inc. (Nasdaq: MEDI) announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favor of expanding the population for use of FluMist (Influenza Virus Vaccine Live, Intranasal) to include children under 5 years of age.

The committee voted that the data demonstrate the efficacy of FluMist in children 6 to 59 months of age.

In addition, the committee voted in favor of the risk-benefit profile of FluMist in children 12 to 59 months of age without a history of wheeze, and voted in favor of the risk-benefit profile of FluMist in children 24 to 59 months of age regardless of a history of wheeze.

"We are very pleased with the committee's endorsement to expand the availability of FluMist to children under 5 years of age," said Edward M. Connor, M.D., executive vice president and chief medical officer. "Pending approval, we believe that FluMist will be an important new alternative for helping to protect this group of vulnerable children from influenza. We look forward to continuing discussions with the FDA in its review of our application."

FluMist, a nasal spray vaccine, is currently approved for healthy children and adolescents 5 to 17 years of age and healthy adults 18 to 49 years of age. The FDA is expected to respond to the company's supplemental biologics licensing application (sBLA) requesting an expanded indication for FluMist in children below 5 years of age by May 28, 2007.

Advisory committees are expert panels who provide the FDA with independent opinions and recommendations on applications related to new and currently marketed drugs, biologics, vaccines and FDA policies. All final decisions related to a regulated product are made by the FDA.

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