Merck's Gardasil not cleared by FDA for older women

New York, NY

U.S. regulators have told Merck & Co they cannot yet approve Merck's application to expand marketing of its cervical cancer vaccine Gardasil to an older group of women, the drugmaker said on Wednesday.

Merck had applied for the use of Gardasil in women ages 27 through 45. The U.S. Food and Drug Administration said in a letter regarding the application that it has completed its review and there are "issues" that preclude approval within the expected review time frame, Merck said.

"It's hard to get a feel for if this is a dead issue or if this is delayed," said Linda Bannister, an analyst for Edward Jones. "At the minimum, it's going to be delayed."

Merck said it also failed to win FDA approval to expand Gardasil to protect against more strains of the Human Papillomavirus that causes cervical cancer. The company for now is dropping plans to pursue that expansion, a spokeswoman said.

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