Glaxo decided that it will add results from an ongoing phase III study called HPV-008 to its original application in the first half of 2009 and a decision by the FDA is expected six months later. The 2007 application now under consideration included only data from an earlier trial.
The delay in the FDA decision on the Glaxo vaccine is a boon for Merck & Co.'s rival Gardasil, which has had the U.S. market to itself since 2006.
Glaxo's Cervarix vaccine claims many additional benefits and the company says that its efficacy lasted longer. However, the FDA is taking more time to approve the vaccine because of the potential risk of side effects.
Glaxo's Phase III clinical trial is measuring Cervarix's safety and efficacy in thousands of women. Cervarix is already on the market in Europe, Mexico, Australia and parts of Asia.
