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Gardasil Rejected for Older Women Again

Jan 12, 2009 | Parker Waichman LLP, LLP

Despite nearly 10,000 reports of adverse reactions, Merck is looking to expand Gardasil approval for older women.  Again.  According to Bloomberg News, the pharmaceutical maker is likely going to experience at least a one-year delay on its plans for such approval due to questions from the U.S. Food and Drug Administration (FDA).

Gardasil was approved by the FDA in June 2006, at which time Merck said clinical trials had shown the drug to be between 90-100 percent effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer.  Shortly thereafter, the U.S. Centers for Disease Control and Prevention (CDC) issued a recommendation that all young girls age of 11 and 12 receive the Gardasil vaccine.  Meanwhile, there have been 9,749 adverse reactions and 21 reported deaths since 2006 in young girls following Gardasil vaccination with side effects that included 10 miscarriages, 78 severe outbreaks of genital warts, and six cases of Guillain-Barré syndrome, an autoimmune disorder that can result in paralysis.  Side effects were reported to the FDA and CDC via the Vaccine Adverse Event Reporting System (VAERS).   Gardasil is approved for females age nine to 26.

Now, the FDA is looking for additional information from a four-year study of Gardasil’s safety and effectiveness before considering its approval for the drug for women ages 27 to 45, reports Bloomberg.  The FDA delayed an earlier request for Gardasil to be approved for use in older women following an expedited review of the drug.

In Western countries like the U.S., regular Pap test screening has greatly reduced the incidence of cervical cancer and death; however, even after vaccination, regular Pap tests are needed since Gardasil does not protect against all HPV strains known to cause the cancer.  According to Tim Anderson, an analyst at Sanford Bernstein & Company, “Gardasil’s efficacy drops sharply once females have been exposed to HPV, and this is probably the genesis of the problem with the older female population that Merck has been pushing for in this new application,” reports Bloomberg.

Anderson said that this second FDA rejection presents, “yet another setback” for Merck; Gardasil is “one of Merck’s key products,” he added, noting 1.5 billion in sales in 2007, according to Bloomberg, which also noted that sales have dropped in the past two years following questions regarding Gardasil’s “cost, safety, and” efficacy.  Merck stocks have fallen 53 percent in the past 12 months, said Bloomberg, which added that Merck is hoping Gardasil will enable the company to recoup some of its lowered profits due to Vytorin, Zetia, and Singulair woes. The vaccine costs about $400 to administer.

Merck plans on responding to the agency by this year’s fourth quarter, said Bloomberg, which explained that this follows Merck’s response to the FDA this summer following the FDA’s first request.  

Last month, Merck applied to the FDA for approval to sell Gardasil for men claiming a 90 percent reduction in risk of genital warts and pre-cancerous lesions.


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