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.

You must be a registered member of MMM to post a comment.
close

Next Article in Channel

 

Did you miss January's Top 40 Healthcare Transformers issue? Read how these inventors, strategists, entrepreneurs and wonks are challenging, disrupting and otherwise transforming the healthcare business. And join us April 30 to honor them at the Transforming Healthcare Dinner. Click here.