FDA Approves Additional Gardasil Indications

Sep 17, 2008
By Pharmaceutical Executive Editors

It’s two more indications for Merck’s “one less” vaccine. On Friday, FDA approved a supplemental label expansion for Gardasil, the company’s human papillomavirus (HPV) vaccine. The product had previously been approved to prevent vaginal and vulvar precancers (though not the cancers themselves) as well as cervical cancer. The new labeling adds vulvar and vaginal cancer to the list.

Unchanged are the population (women aged nine to 26) and the type of HPV covered by the vaccine (types 16 and 18).

After Gardasil’s initial approval in 2006, Merck continued to track 15,000 patients who had participated in the vaccine’s original clinical trials, with half receiving Gardasil and half a placebo. According to an FDA statement, the half treated with Gardasil did not develop any precancerous lesions, while ten patients in the control group developed vulvar lesions and nine developed vaginal lesions attributed to HPV types 16 or 18.

“There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same viruses for which it helps protect against cervical cancer,” stated Jesse L. Goodman, director of the FDA’s Center for Biologics Evaluation and Research in a release. “While vulvar and vaginal cancers are rare, the opportunity to help prevent them is potentially an important additional benefit from immunization against HPV.”

Merck spokesperson Amy Rose told Pharm Exec on Monday that it is premature to announce any changes in marketing tactics. Gardasil has received numerous awards and recognitions for its edgy ad campaign that features young girls proclaiming that they want to be “one less statistic.”

“We were pleased to see Dr. Goodman’s comment about the strong evidence that this vaccine will help prevent these two additional cancers in addition to the cervical cancer prevention that it was already approved for,” Rose said. “It’s a significant milestone for Gardasil.”

In June, FDA denied approval for a supplemental use of the vaccine in adult women age 27 through 45. Merck responded to the FDA in July and is awaiting reply. Clinical trials are also underway in males, according to Rose.

Why men?

“There are some rare forms of cancer and there is also herd immunity—if you inoculate everyone, then no one is a carrier,” Rose said. “If males were to be vaccinated, they couldn’t infect females who may or may not be vaccinated. With vaccine theory, you would optimally want to vaccinate as much of the eligible population as possible.”

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