GSK Submits Cervarix Application to FDA

GlaxoSmithKline (GSK) announced it has submitted a biologics license application (BLA) for its human papillomavirus (HPV) vaccine, Ceravix, to the FDA. If licensed, the vaccine will be indicated for the prevention of cervical cancer and precancerous lesions associated with the most common cancer-causing HPV types.

The BLA for the GSK cervical cancer candidate vaccine includes data from clinical trials in almost 30,000 females 10 to 55 years old and reflects an ethnically diverse population. The submission also contains data from the largest Phase III cervical cancer vaccine efficacy trial to date, which was conducted around the world in more than 18,000 females.

The vaccine is formulated with a proprietary adjuvant system called AS04, containing aluminum hydroxide and monophosphoryl lipid A. Published data have shown that the GSK cervical cancer candidate vaccine formulated with AS04 provides a stronger and longer-lasting immune response compared with the same GSK vaccine composition formulated with a traditional aluminum hydroxide adjuvant.

In January GSK said it planned to undertake a 1,000-patient head-to-head trial comparing Cervarix with Merck's HPV vaccine Gardasil.

In addition to the application submitted to the FDA, GSK has filed applications with regulators in Europe, Australia, Canada and countries in Asia and Latin America.