U.S. regulators have told Merck & Co they cannot yet approve Merck's application to expand marketing of its HPV vaccine Gardasil to an older group of women, the drugmaker said 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.
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.
Gardasil wa approved in June 2006 for preventing cervical cancer and genital warts in females ages 9-26. A Merck spokeswoman said the agency has specific questions regarding Gardasil's effectiveness in an older age group.
The company said it had already discussed the questions with the FDA and expects to respond to the agency in July. "Once we go back to the FDA, we'll have a better sense of what the review timing looks like," spokeswoman Amy Rose said.
Reviewed by Ramaz Mitaishvili, MD
