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Merck's Gardasil Cleared by FDA

Robert Steyer

The Food and Drug Administration approved Merck's (MRK Quote) Gardasil, the first vaccine against a virus that causes cervical cancer and genital warts.

The agency gave the product broad approval Thursday, saying that the vaccine is appropriate for treating girls as young as 9 years old and women as old as 26.

The vaccine is approved for two types of human papillomavirus, or HPV, that Merck says accounts for 70% of cervical cancers. The vaccine also prevents two types of HPV that account for 90% of genital warts.

FDA approval for a product that many analysts say could eventually produce $1 billion or more in annual sales came three weeks after a group of outside medical experts unanimously endorsed the vaccine.

Shares of Merck were little changed, gaining 1 cent to $33.97.

The agency's action gives Merck a head start against GlaxoSmithKline (GSK Quote), which is developing the HPV vaccine called Cervarix. GlaxoSmithKline expects to file an application with the FDA by the end of the year.

"This vaccine is a significant advance in the protection of women's health in that it strikes at the infections that are the root cause of many cervical cancers," said Dr. Andrew C. von Eschenbach, acting commissioner of the FDA.

"Use of Gardasil can help significantly reduce the human and economic burden of cervical cancer, precancerous or low-grade lesions and genital warts," said Dr. Kevin Ault, associate professor in the department of gynecology and obstetrics at Atlanta's Emory University School of Medicine, in a press release issued by Merck. Ault was the clinical study investigator for Gardasil.

The vaccine is now available for ordering. The Gardasil regimen requires three injections over six months. Merck is charging $120 per dose. The company has created a new program in which it will provide free vaccines to adults who are uninsured and can't afford vaccines. Merck vaccines, including Gardasil, will be covered by this program in the third quarter.

The FDA notes that Merck will conduct additional studies, including those to further evaluate Gardasil's safety and long-term effectiveness. Merck will monitor women who receive Gardasil while unknowingly pregnant, and the company also is studying whether Gardasil is safe and effective for treating genital warts in males.

Merck licenses the Gardasil technology from CSL Ltd. of Australia. The vaccine was approved in Mexico last week. Merck has filed applications in five continents, including the large European Union market as well as Australia, Argentina and Brazil. The company is also trying to expand Gardasil's availability to developing countries.

The FDA says human papillomavirus is the most common sexually transmitted infection in the U.S. The Centers for Disease Control and Prevention estimates that about 6.2 million Americans become infected with genital HPV each year and that more than half of all sexually active men and women become infected at some time in their lives.

On average, there are 9,710 new cases of cervical cancer and 3,700 cervical-cancer deaths each year in the U.S. Worldwide, cervical cancer is the second most common cancer in women, with an estimated yearly toll of 470,000 new cases and 233,000 deaths.

Merck says it is important to vaccinate girls and women with Gardasil before they are exposed to HPV. "Adolescents are an important group to vaccinate against HPV. "One in four people ages 15 to 24 are infected with HPV," the company says.

The FDA was more blunt, saying the vaccine is only effective when given prior to infection. However, Merck says that if Gardasil is given to a woman infected with one type of HPV targeted by the vaccine, she still could be protected from the three other types covered by the vaccine.

Because Gardasil doesn't protect against less common types of HPV, the FDA says routine and regular pap tests "remain critically important to detect precancerous changes in the cervix to allow treatment before cervical cancer develops."

The FDA approved the vaccine based on four clinical trials involving 21,000 women ages 16 to 26 who were given Gardasil or a placebo. "The results showed that in women who had not already been infected, Gardasil was nearly 100% effective" in preventing certain precancerous lesions and genital warts caused by the HPV types targeted by the vaccine, the FDA says.

"While the study period was not long enough for cervical cancer to develop, the prevention of these cervical precancerous lesions is believed highly likely to result in the prevention of those cancers," the FDA says.

The FDA decided to approve the vaccine for younger girls based on two studies that measured their immune systems' response, showing that this response "was as good as that found in 16-26 year olds, indicating that the vaccine should have similar effectiveness when used in the 9- to 15-year age group."