Drugmaker Merck
said Monday that it submitted a marketing application to
the Food and Drug Administration for its cervical cancer
vaccine Gardasil. The company said the agency now has
up to 60 days to accept the application for review.
In October, Merck
reported that a late-stage clinical trial of more than
10,000 women showed that none who had been given the
vaccine developed cervical cancer or precancerous
lesions over an average two years of follow-up. Of the
women given placebo shots, 21 developed cancer or
precancerous lesions.
The vaccine is
designed to protect against two types of the sexually
transmitted human papillomavirus that cause about 70% of
cervical cancer cases and two other viruses that
account for up to 90% of genital wart cases.
Merck said it
also plans to submit applications for the vaccine in
European Union and Australia and other markets well into
early 2006. (AP)