Glaxo once again seeks FDA OK for Cervarix

At long last, GlaxoSmithKline has filed its last batch of data supporting its application for the cervical cancer vaccine Cervarix. Already approved in 90 countries, Glaxo will once again attempt to get a regulatory approval for Cervarix after losing a significant amount of market momentum to Merck's Gardasil.

"We are pleased to have reached this significant milestone for Cervarix. The data submitted to the FDA reaffirm our confidence in the vaccine's safety and efficacy profile," said Dr. Barbara Howe, vice president and director of Glaxo's North American Vaccine Development unit.

Glaxo was turned down by the FDA two years ago, with regulators looking for more long-term data. Now the pharma giant wants to get an approval after Merck has begun to see its revenue from Gardasil shrink. That's a sign that even with a regulatory win in the U.S., it's too late for Glaxo to gain the kind of megablockbuster revenue it once anticipated. While revenue for a new drug typically takes years to peak, a vaccine starts strong and then declines.

- read the AP story