Cervarix denied FDA priority review
GlaxoSmithKline said yesterday that the FDA has denied the drugmaker its request for a priority review of its experimental cancer vaccine Cervarix.
Cervarix now faces a standard 10-month review, instead of the six-month review usually granted under a priority review.
A priority review is often only granted to new treatments when no drugs are available for a particular illness. However, Cervarix rival, Merck’s Gardasil, is already on the market.
GSK expects a Cervarix action date by the FDA in January 2008.