Biotech Values

[Biowatch]

FDA Issues Warning Letter, Delays FluMist Approval for MedImmune

[Oops. They really don't want to miss the next flu season if they want to get Flumist off the ground. Chiron had manufacturing issues with their UK plant in 2004 which put a major dent in the U.S. vaccine supply. MEDI doesn't sell nearly as many doses of Flumist, but the refrigerator stable version and approval for use in young children should have given them a boost.]

By JENNIFER CORBETT DOOREN
May 29, 2007; Page D2

WASHINGTON -- The U.S. Food and Drug Administration issued MedImmune Inc. a warning letter for violating the agency's manufacturing rules and held off approving the company's influenza vaccine for use in children younger than age five until the problems are resolved, the company said Friday.

MedImmune, based in Gaithersburg, Md., said the FDA found "compliance issues" during a March 2007 annual inspection of plant in the United Kingdom where it makes bulk material for FluMist.

MedImmune, which is being acquired by AstraZeneca PLC, is seeking FDA permission to market the vaccine in children as young as age one without asthma or a history of wheezing. FluMist, a nonshot vaccine that's administered through the nose, is currently approved for use in people ages five to 49 years old.

MedImmune said it and the FDA agreed to final product labeling for FluMist but final approval hinges on resolving compliance issues at the manufacturing plant. MedImmune didn't disclose the contents of the warning letter but said it would be posted Tuesday on the FDA's Web site.

In a statement, the company said it was working with FDA to resolve problems at the manufacturing plant and to be able to release FluMist for the upcoming 2007-2008 influenza season on time.

MedImmune said FDA's action won't have an impact on the acquisition of the company by AstraZeneca.

Earlier this month, an FDA panel of outside medical experts said FluMist was effective at preventing the flu in children as young as six months old and was safe for use in children ages two and older regardless of wheezing history. The agency has said it had some safety concerns about FluMist in children younger than 24 months of age. The FDA typically follows its panel's advice but is not required to.

Write to Jennifer Corbett Dooren at [e-mail]
URL for this article:
http://online.wsj.com/article/SB118012934392715142.html

Some of the Chiron history (although it is unrelated):
http://www.fda.gov/oc/opacom/hottopics/chronology1016.html