FDA APPROVES MEDIMMUNE'S REFRIGERATED FLUMIST

MedImmune announced that the FDA has approved the company's new refrigerated formulation of FluMist (influenza virus vaccine live, intranasal) for use in helping to prevent influenza in healthy children and adults from 5 years to 49 years of age.

"The new formulation can be conveniently stored in a standard refrigerator rather than frozen, as previously required," Frank Malinoski, MedImmune's senior vice president for medical and scientific affairs, said. "We recognize that the frozen storage presented difficulties for some physician practices as well as for providers who administer vaccine in places like schools, pharmacies and grocery stores, and we are confident that this improvement will enhance access to this important vaccine."

FluMist has been marketed in a frozen formulation since its approval in 2003. The newly approved formulation will be available for the 2007-2008 influenza season.

The company's next goal for FluMist is to expand the pediatric indication. To date, 42 clinical trials have been conducted in approximately 60,000 individuals, including children as young as 6 weeks old. In a pivotal Phase III study involving approximately 8,500 children between 6 months and 59 months old, FluMist demonstrated a statistically significant 55 percent relative reduction in the incidence of influenza illness caused by any influenza strain including both matched and mismatched strains when compared with the injectable influenza vaccine.

The study was submitted to the FDA in July 2006 as the basis of MedImmune's request to expand the age indication for FluMist to include children as young as 1 year old who do not have a history of wheezing or asthma. Pending the FDA's approval of the expanded age indication, MedImmune plans to increase production of its new formulation of FluMist for the 2007-2008 season.