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Subscribe To Our Syndicated NewsCervarix Vaccine Approval Delayed
-June 30, 2008
According to reports, GlaxoSmithKline doesn’t expect for its main cervical cancer vaccine to gain FDA approval in the U.S. until 2009.
The manufacturing company expected to get approval earlier, but research is still being conducted on the vaccine.
Delay Announced
The approval delay was announced early this week and brought good news to other manufacturers, like Merck & Co Inc, who produce the rival vaccine, Gardasil.
A spokesman for Glaxo says the company responded to questions and concerns involving their vaccine, Cervarix.
However, they have decided to augment the application using the results of a recent Phase III study, known as HPV-008.
Trial Hoped to Influence Approval
The data Glaxo intends to submit results from a trial being conducted to the U.S. regulator in the first half of 2009 and anticipate the approval should happen six months later.
“Study 008 is a key study that will be completing later this year, and we expect the final results will strengthen the U.S. label for Cervarix,” says Barbara Howe, the head of the Glaxo’s North American Vaccine Development.
(Source: Reuters)
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