Drug maker, Merck, has given the FDA new data to win approval to market its HPV vaccine, Gardasil, to women between the ages of 27 and 45. The drug is already approved to protect girls and younger women, ages 9 through 26, from four strains of the human papillomavirus, which can lead to cervical cancer and warts. The vaccine also won approval to prevent genital warts in young males.
The drug has not been the blockbuster that Merck wanted so it has been trying for some time to win further FDA approval. In June 2008, the FDA rejected Merck’s application to expand use of the drug. And early last year, the FDA again withheld approval, asking Merck for more data on a 48-month study.
After a much heralded approval in 2006, Merck pushed and almost received approval for mandatory vaccinations for young girls. But there was a backlash when it was found that lobbyists were targeting female legislators to introduce new laws in their states. Gardasil sales slowed and now Merck faces competition from its rival, Cervarix, made by GSK.
Then there are the reports, though few, of girls who have had an adverse reaction to Gardasil including paralysis and death. Those have been reported to the FDA and the group, Judicial Watch, published the adverse events reports on its Web site after filing a FOIA with the FDA to obtain the information.
The final blow came from the New England Journal of Medicine that predicted added life expectancy by giving Gardasil to women older than 18 does not justify the cost, which is about $360 for a three-shot dose.