FDA: Merck can't market cervical cancer vaccine to women 27-45

NEWARK, N.J. -- The drugmaker Merck & Co. said Wednesday that the Food and Drug Administration has rejected expanding the use of cervical cancer vaccine Gardasil to include women ages 27 to 45.

The agency cited "issues that preclude approval" within the expected review timeframe, Merck said.

Gardasil was approved in 2006 for girls and women between 9 and 26 years old to prevent cervical cancer caused by the human papillomavirus. The agency's current action does not affect this population's use.

The FDA decision bars Merck from marketing Gardasil to women ages 27-45, but does not prevent those women from getting the vaccine from their doctors.

Merck said that the agency identified several issues related to the application in a "complete response" letter, including stating that the data submitted does not support extending Gardasil's use to include non-vaccine HPV types.

Merck also reaffirmed its goal of attaining compound annual growth of between 4 percent and 6 percent from 2005 through 2010.

Gardasil is the only cervical cancer vaccine approved for the lucrative U.S. market. It is outselling another vaccine, Cervarix, from GlaxoSmithKline PLC, in worldwide sales, analysts said, garnering over $1 billion in sales since its June 2006 U.S. launch.

"This is clearly not what Merck wanted. It reflects the painstakingly slow process that the FDA has in approving anything," WBB Securities analyst Steve Brozak said. "I think this is one where they would rather err on the side of getting another 23 pounds of documents."

Whitehouse Station-based drug maker Merck said it has already had discussions with the FDA and plans to respond next month.

Merck shares fell 27 cents to $36.76 in afternoon trading Wednesday.