A priority designation is intended for products that address unmet medical needs. The FDA aims to review applications with such designations within six months of receipt; in this case it expects to have a decision for Merck by June 8, 2006.
Gardasil, Merck’s investigational cervical cancer vaccine, is designed to protect against four types of human papillomavirus (HPV): types 16 and 18, which account for an estimated 70% of cervical cancer cases and HPV types 6 and 11, which account for an estimated 90% of genital wart cases.
The vaccine caused excitment in October of 2005 when phase III clinical trial results were published suggesting the vaccine to be 100% effective in preventing early stage cervical cancer.
Since submission to the FDA in December, Merck has also submitted applications for Gardasil to additional regulatory agencies including those in the Europe, Australia, Mexico, Brazil, Argentina, Taiwan and Singapore.
In 1995, Merck entered into a license agreement and collaboration with CSL Limited relating to technology used in Gardasil. The vaccine is also the subject of other third-party licensing agreements.