For Merck, this is ‘one less’ approval. The agency bounced the drugmaker’s request to approve its HPV vaccine for women between ages 27 and 45, citing “issues that preclude approval within the expected review timeframe,” but there was no more specific info provided in Merck’s statement.

The drugmaker says it has already discussed with the FDA the questions related to the application and expects to respond to the agency next month. Gardasil, you may recall, was approved in 2006 for girls and women between 9 and 26 years old to prevent human papillomarivus, or HPV, which can lead to cervical cancer caused by the human papillomavirus.

Merck, however, added the FDA identified several issues related to the application in a “complete response” letter, including stating that the data submitted do not support extending Gardasil’s use to include non-vaccine HPV types, or cross protection.

UPDATE: In an investor note, pharma analyst Barbara Ryan of Deutsche Bank writes: “This suggests that Merck believes it has the data in hand to adequately address the concerns, which likely center around efficacy rather than safety considerations. Nevertheless, the timing of the complete response and the subsequent additional review period remain unclear.

“We view the age extension indication as an incremental commercial opportunity, but one where we would also expect a much lower penetration rate. Merck has previously indicated that…use for males, which we believe is the most important incremental opportunity for Gardasil, will be filed later this year.”