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FDA rejects Merck's Gardasil for women over 26
The FDA has rejected Merck's ($MRK) request to market its HPV vaccine Gardasil to women between the ages of 27 and 45. The company had hoped the expanded use could boost slumping sales, which dropped 12 percent to $988 million in 2010, despite the 2009 addition of men and boys ages 9 to 26 to the potential patient list. Recently, the shot was also approved for anal cancer prevention.
According to Merck's release, the vaccine failed to provide adequate results for trial patients and also didn't prevent cervical dysplasia or other HPV-related diseases in the 27 to 45 age range. The FDA added this data to the prescribing information.
Merck first approached the FDA for approval among older women in 2008, but the agency postponed its decision three times as it asked for more information from the company. Gardasil faces competition from GlaxoSmithKline's Cervarix, which won approval in late 2009.
- here's the Merck release
- read the Bloomberg article
- see the post from the Wall Street Journal
Related Articles:
Study: Gardasil effective in boys, men
Anal cancer vax gets FDA green light
HPV shot provides sustained protection against pre-cancerous growths
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