Cervarix denied FDA priority review

Share this article:

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.

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Channel

This compelling e-book shares a wealth of insights designed to help members of sales forces connect with elusive HCPs. An expanded version has also been created that includes video interviews and other multimedia content. Click here for access.