FDA grants fast review of Gardasil for adult women

[joreth]

 The next installment of my HPV updates.

Previous installments that include a more detailed background of HPV and its treatments are:
http://joreth.livejournal.com/65765.html - HPV responsible for Oral Cancers
http://joreth.livejournal.com/21110.html - Carrageenan as an HPV preventative
http://joreth.livejournal.com/49944.html - Possible treatments of HPV in testing phases
http://joreth.livejournal.com/20984.html - Central Florida testing options
http://joreth.livejournal.com/63666.html - Better information for Central Florida testing options
http://joreth.livejournal.com/65916.html - A rant about conspiracy theorists that includes actual statistics for the possible health risks of the HPV vaccine

And now, the latest:

http://www.reuters.com/article/domesticNews/idUSN1932487620080319

FDA grants fast review of Gardasil for adult women

NEW YORK (Reuters) - Merck & Co on Wednesday said U.S. regulators have granted a priority review for the company's application to expand marketing of its Gardasil cervical cancer vaccine to women aged 27 through 45.

The designation means that the U.S. Food and Drug Administration is expected to make its decision on the marketing application within 6 months, rather than within the agency's typical 10-month review period.

Gardasil, one of Merck's fastest-growing products, is currently approved for girls and women nine through 26 years of age. It works by preventing infection with four sexually transmitted strains of the Human Papillomavirus that cause most cases of cervical cancer.

Leerink Swann analyst Seamus Fernandez called the priority review a positive surprise. In a research note, he predicted a "straightforward" regulatory review of the expanded marketing application due to the lack of serious side effects among adult women receiving Gardasil in clinical trials.

Gardasil had fourth-quarter global sales of $339 million, helping to drive Merck's total global revenue from vaccines to $1.1 billion.

Comments

[serolynne.livejournal.com]

That's very hopeful news.. thanks for spreading the word. I keep hoping for news of more approval for the vaccine in use for men too.


Also, may I pass along your post (with credit) about Central Florida testing option within my 'Practical STD Management' workshop at FPR?

[joreth]

Absolutely - if I were still a member of the Polyamory LJ community, I'd post it all there too. I know some people who won't get tested because they think it's too expensive (some are young college students with no jobs, some are coworkers who can't budget their money, some are just afraid of the results and use money as an excuse) and I want everyone to know of the low-cost options because I think it's worth it to eat Ramen for a couple of weeks to save up the $45 and go to the county for an exam.

I have the chart in a more format-able file if you'd like it

[serolynne.livejournal.com]

That would be awesome.. thanks.

I'll be doing a section on the financial aspects of STDs, and I'd like to be able to present options other than 'traditional' health care avenues to show that keeping on top of testing/treatment doesn't have to cost a fortune if you don't have health insurance that covers it (and even pointing out that getting HIV testing under health insurance can impact your insurability.) What a screwed up health care system we have.