That Happened!

New York - The FDA has declined to approve Gardasil for women 27 to 45, stating that it needs additional information before it will approve Merck’s cervical cancer vaccine. Girls aged 9 to 26 are already approved to receive Gardasil, but in the face of disappointing sales to this age group, this is the second attempt by Merck to expand the approved age group. Merck has also recently sought to gain FDA approval to give the vaccine to boys.

Gardasil protects girls and women against some forms of the human papilloma virus that cause most cervical cancers, as well as some vulvar and vaginal cancers. The vaccine is also approved to protect girls and women against getting genital warts, which are also caused by the HPV virus. The FDA’s approval process for Gardasil hinges upon the fact that the vaccine is only fully effective for girls and women who have not yet been exposed to the papilloma virus. Girls and women who have not yet become sexually active are most likely to have not been exposed.

The FDA has asked the makers of Gardasil to provide expanded data, including information from a 4 year study that has not yet been completed, in order to make a final determination of whether Gardasil will be approved for women 27 to 45. Merck expects to submit these results to the FDA by the end of 2009, so the FDA will not be able to grant approval until 2010 at the earliest.

This is the second time the FDA has delayed a decision on Gardasil for women older than 26. In June of this year, the FDA also asked Merck to produce more information to support the expansion of Gardasil’s use. Merck responded by providing interim data from its ongoing 4 year study. The FDA presumably needs more data to make its decision, because it has now decided to delay the decision until final results are in from the 4 year study.

In response to the FDA’s refusal to approve Gardasil for the expanded age group, Merck’s shares were down by 2% this morning. Merck has struggled with disappointing sales of Gardasil this year and forecasts flat sales for 2009, driven in part by lackluster consumer response to the vaccine, as well as reports that the vaccine does not work as well as expected. Consumers may have also balked at the vaccine’s high price point — about 360$ for three doses given over a period of six months. Although many insurance carriers will pay for the vaccine, some will not, leaving consumers to fund the expensive vaccine themselves.

The expansion of Gardasil to women older than 26 was expected to boost overall sales, but only modestly, since it was unclear whether there would be robust demand for a vaccine that may only provide a small protective benefit to women who are already sexually active. The expansion of Gardasil to boys and young men, which may be approved by the FDA later this year, may turn out to be a more lucrative market for Merck.