The FDA has granted GlaxoSmithKline's cervical cancer vaccine Cervarix a standard 10-month review rather than a priority review, which could have seen the drug hit the market in six months.
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The decision means that Merck & Co.’s rival product Gardasil, which is already available in the US, will remain unchallenged until 2008, when GSK expects to launch Cervarix. However, the vaccine has already been approved in Australia, and the company is expecting to launch the vaccine in Europe during the second half of 2007.
A priority review is normally only granted for new treatments, where no drugs are currently available for a particular illness.