Merck receives response letter from FDA for use of Gardasil

The agency issued the letter to advice 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 has already discussed with FDA their questions related to this application and expects to respond to the Agency in July.

Merck submitted the supplemental biologics license application (sBLA) for use in this expanded population in January 2008 and in March 2008 the FDA designated the submission a priority review. The letter does not affect current indications for Gardasil in females aged nine through 26.

The FDA has also issued a complete response letter regarding the sBLA for the use of Gardasil against non-vaccine types. According to the FDA, the data submitted do not support extending the indication for Gardasil to include non-vaccine human papillomavirus (HPV) types.

Beverly Lybrand, senior vice president and general manager of adolescent/adult vaccines at Merck, said: “Merck is proud that Gardasil continues to be the world’s leading cervical cancer vaccine. We are committed to seeing Gardasil used to help prevent cervical cancer and other HPV diseases in the currently indicated population.”