Merck submits FDA
application for cervical cancer vaccine

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)