A decision on whether to approve Merck & Co.'s human papillomavirus (HPV) vaccine Gardasil for use in older women has been pushed back to the end of the year, a Food and Drug Administration spokesperson said this week. Merck had been expecting an FDA decision this week on its request to make the drug available to women up to age 45.
Gardasil currently is approved for both males and females ages 9-26 to prevent two strains of HPV that can cause genital warts. Among women ages 9-26, the vaccine also is indicated for preventing two HPV strains linked to cervical cancer.
FDA did not comment on why the decision had been delayed. Merck spokesperson Pam Eisele said the company is working with FDA "to determine an appropriate way" to incorporate data from Merck's study of Gardasil in older women into the vaccine's prescribing information.
Merck first sought regulatory approval two years ago for the use of Gardasil among older women. The company documented that, after about two years of follow-up, the vaccine was effective in preventing certain precancerous lesions caused by HPV among women up to age 45.
FDA sought data for over a longer term, after four years of follow-up. That information was provided to FDA in 2009 and publicly released in the beginning of this year.
The four-year data looked at women who were uninfected by the four types of HPV targeted by Gardasil. Four-year efficacy was 88.7 percent, compared to 91 percent efficacy after two years.
06/16/10
UNITED STATES: FDA Extends Review of Gardasil’s Use by Older Women
Source: Wall Street Journal:: Peter Loftus; Courtesy of the CDC National Center for HIV, STD, and TB Prevention