Merck asks FDA to expand Gardasil use

Anyone who's been following the vaccine trade knows that Merck is working hard to expand the use of its human papillomavirus shot. Now approved for marketing to girls and young women, Gardasil has been tested on boys, young men and on women as old as 45, with the aim of growing the potential HPV market beyond preteen, teenage and early-twenties females.

Now, Merck has officially asked the FDA to give Gardasil its blessing for use in males aged 9 to 26 years old, CNBC reports. The indication for boys and young men would be for prevention of genital warts and other lesions. One of the studies underlying Merck's application is a recent trial analysis showing that 90 percent fewer young men developed those problems after receiving Gardasil.

As you know, Merck is also awaiting word from the FDA about expanding Gardasil's use to 27-to-45-year-old women.

The HPV vaccine is a big deal at Merck, with estimated 2008 sales of up to $1.6 billion. But sales have slowed down, the Health Blog notes, with a 4 percent drop in the third quarter of 2008, compared with the third quarter of 2007. That's at least in part because of the treatment population problem. Approved and recommended in 2006, Gardasil was quickly adopted by a chunk of its target market, leaving fewer targets to market to; that created a surge in sales followed by a natural slowing. With a couple of new populations, Gardasil could surge forward once again.

The question that's likely to arise is whether Gardasil is actually worth the price. Some mathematical analyses have found that the cost to society of cervical cancer and genital warts doesn't necessarily outweigh the cost of vaccinating women on the upper end of the age bracket. And in males, HPV is usually not fatal and often symptomless--compared with the greater incidence of both outcomes in females. So while the shot might get the FDA's stamp of approval, it might not be quickly adopted by the insurers--or patients--who'd be paying for it.

- read the Health Blog post [1]
- check out the news [2] at CNBC
- see the BNet article [3]

Related Articles:
In Phase III, Gardasil prevents HPV in men [4]
HPV researcher calls for vaccination of males [5]
Critics accuse Merck of hyping cervical cancer risk [6]
FDA grants Gardasil two new indications [7]
HPV vaccine makes inroads, CDC says [8]