In a blow to Merck's campaign to expand use of its human papillomavirus vaccine, the FDA denied the drugmaker's request to market Gardasil to older women. The vaccine is currently approved for girls who are at least 9 years old and for young women up to the age of 26, as well as for boys and young men.
Merck had been on a roll, winning bids to expand Gardasil use beyond its initial indication for prevention of cervical cancer and genital warts in girls and young women. Merck got the FDA nod for Gardasil as a shield against vulvar and vaginal cancers in the same age group, then won the OK to market it as a preventive for genital warts in boys and young men. Last December, the FDA approved Gardasil as a preventive for anal cancers.
But the expansion of Gardasil's label to cover older women has remained stubbornly elusive. In 2009, the FDA put off Merck's request, asking for more data. The company submitted more data early in 2010, but then the FDA postponed its decision. And now, instead of approving the new use, FDA asked Merck to revise the label to say that Gardasil has not proven effective at reducing HPV-related cervical cancers in women over the age of 26.
Merck had been counting on the new use to help reverse a sales slide. Last year's sales of $988 million were down 12 percent from the previous year, Bloomberg reports. As Pharmalot notes, Gardasil brought in $1.48 billion in 2007, $1.4 billion in 2008, and $1.1 billion in 2009.