GlaxoSmithKline Submits BLA for Cervarix HPV Vaccine

PHILADELPHIA, Pennsylvania—GlaxoSmithKline has submitted to the FDA a Biologics License Application (BLA) for Cervarix (human papillomavirus vaccine, AS04 adjuvant-adsorbed), its cervical cancer candidate vaccine. The vaccine is formulated with a proprietary adjuvant system called AS04 containing aluminum hydroxide and monophosphoryl lipid A. The submission includes data from clinical trials in almost 30,000 females age 10 to 55 reflecting an ethnically diverse population, the company said.