Merck gets is ‘One Less’ FDA Approval
The FDA rejected Merck’s request to approve its HPV vaccine, Gardasil for women between ages 27 and 45, citing “issues that preclude approval within the expected review timeframe,” Merck offered no additional specific explanation in their prepared statement.
Merck indicated that it is in ongoing discussions with FDA officials about to the application and expects to officially respond to the agency within the next 30-days. The HPV- vaccine, Gardasil, was approved June 8, 2006 for girls and women between 9 and 26 years old to prevent human papillomarivus related cervical cancer.
Merck statement noted that the FDA identified specific issues related to their application to expand the use of the HPV vaccine, Gardasil to women between ages 27 and 45, in a “complete response” letter, including statement that indicated the data submitted do not support extending Gardasil’s use to include non-vaccine HPV types, or cross protection.
Pharma financial 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.”