FDA grants Gardasil two new indications

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 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
- check out the story in the New York Times

Suggested Articles

Ebola has claimed thousands of lives in recent outbreaks, but now the world has a licensed vaccine option in Merck's Ervebo.

Drugmakers have voluntarily recalled their generic Zantac from the U.S. market after the FDA raised concerns, but it has not been without a cost.

The role of distributors like AmerisourceBergen, is to ensure patients can get access to therapies, no matter where they present.