Two out of three ain't bad. Yesterday, Merck's HPV shot Gardasil saw a potential competitor step closer to the market. But it also won an FDA advisory panel recommendation for approval to prevent genital warts in young men. And it got the nod from European regulators for use in women up to the age of 45.
Merck has been casting about for new indications for the human papillomavirus shot to help combat falling sales. The vaccine to prevent cervical cancer and genital warts roared onto the market in 2006, but since then has decelerated. So the company is aiming to broaden its potential market. It failed to persuade FDA to broaden use to older women--up to the age of 45--but now has convinced an agency advisory committee that Gardasil would be useful for boys and young men.
A few panelists--and at least one analyst--point out that approval for use in males doesn't necessarily mean males will use it. The series of three shots is expensive, around $400, and will require three visits to the doctor over a six-month period. And this to prevent a nonfatal venereal disease. "Pretty much no healthy teen would ever do that," Tim Anderson, analyst with Sanford C. Bernstein, told the New York Times.
Merck is expected to argue for vaccination of boys and young men in part to help protect girls and young women. But it remains to be seen whether that "herd immunity" argument will work on parents and insurers who have to pay for the shot.
The European approval, meanwhile, addresses cervical cancer, which is potentially fatal. European regulators gave the nod to expand use of Gardasil to women up to age 45, when previously it was only indicated for those up to age 26. In Europe, the vaccine is marketed by Sanofi Pasteur MSD, a joint venture between Merck and Sanofi-Aventis. In the U.S., the FDA has asked Merck for more data on Gardasil use in women 27 to 45 years old; the company expects to provide that info by the end of this year.
- check out the Sanofi Pasteur MSD release
- find the release from Merck
- see the NYT story
- get the piece from CNN
- read the Wall Street Journal article