The US FDA vaccines and related biological products advisory committee voted unanimously that the data from phase II and phase III clinical trials support the efficacy and safety of Gardasil, Merck's investigational cervical cancer vaccine, [quadrivalent human papillomavirus (Types 6, 11, 16, 18) recombinant vaccine] for the prevention of cervical cancer and for the prevention of cervical, vulvar and vaginal pre-cancers caused by human papillomavirus (HPV) types 16 and 18 in females. The committee also agreed that data supports the efficacy and safety of Gardasil for the prevention of other cervical, vulvar and vaginal lesions caused by HPV types 6, 11, 16 and 18 including genital warts.
The committee's guidance will be considered by the FDA in its review of the Biologics License Application (BLA) that Merck submitted for Gardasil in December 2005. The FDA has informed Merck that the target date for completion of review is June 8, 2006. The FDA is not bound by the committee's guidance, but takes its advice into consideration when reviewing investigational vaccines seeking approval.
"Merck is thrilled that the advisory committee has agreed that the extensive data from our decade-long, 27,000-patient clinical trial program support the use of Gardasil to reduce the burden of cervical cancer and other diseases caused by HPV," said Peter S. Kim, president, Merck Research Laboratories. "If approved, Gardasil will be the first and only vaccine to prevent cervical cancer and other serious HPV-related diseases. We look forward to bringing this vaccine to people to continue our legacy of bringing forward novel medicines and vaccines that address unmet medical needs for people around the world."
Gardasil is Merck's investigational cervical cancer vaccine designed to protect against four types of human papillomavirus (HPV types 6, 11, 16 and 18).
In studies, Gardasil prevented 100 percent of cervical cancers and pre-cancers caused by HPV types 16 and 18.
In 1995, Merck entered into a license agreement and collaboration with CSL Limited relating to technology used in Gardasil. It also is the subject of other third-party licensing agreements.