An FDA advisory panel agreed Wednesday that MedImmune’s FluMist nasal spray flu vaccine is safe and effective in children 2 and older.
The vaccine is currently approved for patients ages 5 to 49. MedImmune is currently seeking approval for FluMist in patients ages 1 to 5 without a history of wheezing or asthma.
Advisory panel members, in a 9 to 6 vote, said company studies show FluMist’s benefits outweighed its risks in children 1 to 5 years old without known respiratory problems. The panel voted 15 to 0 that if a child does wheeze, the vaccine should be used in only those 2 and older. Advisers voted 12 to 3 against recommending FluMist use in wheezy children younger than 2.
The FDA isn’t required to follow the advice of its advisory panels but often does.
FluMist was first approved in 2003. Sales of the drug reached $36 million in 2006.
Last month, MedImmune agreed to be purchased by AstraZeneca for $15.6 billion.
Yesterday, a MedImmune investor yesterday filed a lawsuit against the biotech firm and its senior officers and directors claiming the sale benefited them more than ordinary shareholders.
MedImmune said it intends to vigorously defend itself.
"We believe the board acted in the best interest of the shareholders in its willingness to accept AstraZeneca's offer to acquire the company," MedImmune spokeswoman Jamie Lacey told Reuters.
An AstraZeneca spokesman told Reuters the UK drugmaker is confident the deal between the two firms will continue.
"This is a matter for MedImmune as AstraZeneca is not party to the suit. However, MedImmune's SEC filing states that it does not believe the suit has any merit. Therefore we are confident that the deal will go ahead," the AstraZeneca spokesman said.
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