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]
Links:
[1] http://www.fiercepharma.com/story/will-gardasil-special-help-merck/2008-08-20
[2] http://www.fiercebiotech.com/press-releases/fda-approves-expanded-uses-gardasil-include-preventing-certain-vulvar-and-vaginal-can
[3] http://www.nytimes.com/2008/09/13/us/13brfs-NEWINFORMATI_BRF.html?ref=us
[4] http://www.fiercepharma.com/story/analyst-gloomy-merck-trends/2008-09-11
[5] http://www.fiercebiotech.com/story/study-questions-gardasils-payback/2008-08-21?utm_medium=rss&utm_source=rss&cmp-id=OTC-RSS-FB0
[6] http://www.fiercepharma.com/story/gardasil-side-effects-prompt-cdc-study/2008-08-13-0
[7] http://www.fiercepharma.com/story/gardasil-worth-cost/2008-08-21
[8] http://www.fiercepharma.com/story/gardasil-remarkably-safe-despite-anaphylaxis/2008-09-03?utm_medium=rss&utm_source=rss&cmp-id=OTC-RSS-FP0