FDA Wants More Gardasil Data
Any hopes Merck had of marketing Gardasil to women aged 27 to 45 in the early part of 2009 have been dashed.
On Friday, the manufacturer of the popular human papillomavirus vaccine announced that FDA has requested final trial data before it makes a decision about whether or not Merck can market Gardasil to this older group of women. The vaccine is currently given in three doses to young women ages nine to 26 to help prevent cervical, vaginal, and other cancers attributed to HPV. Last week, Merck announced that it had submitted separate data to FDA showing the positive effects of Gardasil in men for the reduction of genital warts.
Gardasil is in the midst of a 48-month trial to determine how effective it is on older women. In 2008, the firm filed a report with FDA listing all the endpoints reached in the first 24 months of the trial. Initial results showed that Gardasil prevented 91 percent of cases of persistent infection, low-grade abnormalities, and pre-cancers in older women. However, FDA wants to review all information once the 48-month study is complete.
The trial is a pre-specified endpoint study, of which most of the endpoints were met at the 24-month time frame, according to Merck spokesperson Amy Rose.
“Once the 48-month trial has concluded, we anticipate providing a response to FDA in the fourth quarter [of 2009],” Rose told Pharm Exec on Tuesday. “The fact is that the pre-specified endpoints were met at 24 months—FDA just wants to see the end-of-study results, which gives them a duration that’s twice as long.”
“While they are both Merck and Gardasil news, one is an application [for extended use of Gardasil],” Rose said. “The change of our franchise leadership is on the marketing/commercial organization side. The two are not related.”
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