FDA delays approval of Wyeth's Prevnar-13

The FDA has delayed approval of Wyeth's Prevnar-13 vaccine for three months as it takes more time to review additional data. In response to an FDA request, Wyeth submitted additional analytical method validation and specification information relating to physical/chemical properties of the product in late July. The FDA considers this a major amendment to the drug's BLA and has elected to move its decision date from September 30 to December 30.

The current version of Prevnar is Wyeth's second-biggest selling brand, with $2.7 billion in sales in 2008. Prevnar 13 guards against the same seven common strains of strep bacteria that the currently used jab can fight, and adds six new strains that also are appearing regularly around the world.

"This is a significant application that is under priority review and we are working closely with the FDA on the review, including conduct of the pre-approval inspections," says vaccine development chief Emilio Emini.  "Priority review designation is given to products that, if approved, would be a significant therapeutic or public health advance.  We continue to believe that our application supports the approval of Prevnar 13."

- here's the report

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