Merck seeks FDA approval for cancer vaccine

Merck has submitted its license application for Gardasil as a vaccine to protect against four types of human papillomavirus (HPV), the sexually transmitted virus responsible for the majority of cervical cancer cases. The company also plans to submit licenses for Gardasil in Europe and Australia, as well as other countries, in December 2005 and early 2006, with the help of its European marketing partner Sanofi Pasteur.

The FDA will determine whether it will accept for review Merck’s application as submitted within 60 days following submission. Merck is seeking priority review designation for Gardasil, which means the product could be on the market in six months rather than the usual ten if it gains favor with the US authority.

The vaccine is designed to protect against four types of human papillomavirus (HPV), namely 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.

Gardasil is directly competing with GlaxoSmithKline’s experimental vaccine Cervarix, which is intended for European submission during the first half of 2006 and will possibly be filed with US authorities before the end of 2005.

Both the Merck and Glaxo vaccines have proved effective in clinical trials in preventing HPV. There is potential controversy for both drugs however, as their use may be targeted towards young girls for whom there would be greatest benefit, causing some to claim the vaccines encourage sexual promiscuity.