CMR

GlaxoSmithKline Vaccine Unlikely To Receive US Approval For 2 Years

London-The new cervical cancer vaccine that has been submitted by GlaxosmithKline for approval in the United States is not likely to receive the go ahead until 2010 at the earliest.

The company has released a new timetable that sets its expectant date for approval of its new Cervarix Cancer Vaccine at 2010 at the earliest.

The Food and Drug Administration has asked for fresh information from the company in December, and then decided to wait upon the completion of a clinical trial in the United States that is considered pivotal.

After the results of the trial are made public the GSK Company believes that its efforts to have Cervarix approved will be made a lot easier.

The company believes that the trial will show the efficacy and positive usage of its new vaccine.

The timetable tends to confirm the longstanding fears in the marketplace that Cervarix would be delayed.

There is a rival vaccine already in the market, Gardasil, which is produced by Merck and it is already on sale in the United States.

The Cervarix vaccine was originally submitted for FDA approval in March 2007 but has since been withdrawn by the company.