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Published on FiercePharma (http://www.fiercepharma.com)

FDA grants Gardasil two new indications

By tracy
Created Sep 15 2008 - 11:01am

Some good news for Merck's Gardasil: The FDA says the human papillomavirus vaccine is approved for prevention of vulvar and vaginal cancers, in addition to its current use as a cervical cancer shot. The new indications come at a good time, when Gardasil was faltering on lower-than-expected use [1] among women 19 to 26. And Merck lost its FDA bid for approval in older women, so it couldn't mount a marketing push for that segment of the market.

Now, the company can tout increased protection. "This is fabulous stuff," said Rick Haupt, Merck's program leader for Gardasil.

Next up: data on the use of Gardasil in men. The company hopes to submit a study in support of that new indication by year's end.

- read the FDA release
[2]- check out the story [3] in the New York Times

Related Articles:
Analyst gloomy on Merck trends [4]
Study questions Gardasil's payback [5]
Gardasil side effects prompt CDC study [6]
Is Gardasil worth the cost? [7]
Gardasil "remarkably safe," despite anaphylaxis [8]


Source URL:
http://www.fiercepharma.com/story/fda-grants-gardasil-two-new-indications/2008-09-15