FDA rejects wider patient age group for Merck & Co's Gardasil

The US Food and Drug Administration has rejected an application for an expanded indication of Merck & Co's cervical cancer vaccine Gardasil to include women aged between 27 and 45. The agency issued the US drug major a letter to advise that it has completed its review of the submission and that "there are issues that preclude approval of the supplement within the expected review timeframe." Merck says it has already discussed with the FDA its questions related to this application and expects to respond to the agency in July. The firm submitted its supplemental Biologics License Application for Gardasil in this expanded population in January and in March the agency designated the submission a priority review. The letter does not affect the current Gardasil indication, approved in 2006, the prevention of cervical cancer caused by the human papillomavirus in females aged nine through 26.