GSK’s Cervarix reaches FDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
GlaxoSmithKline is requesting a priority review of its human papillomavirus vaccine Cervarix, submitted March 29. The BLA is based on data from clinical trials in almost 30,000 females ages 10-55. One trial showed that Cervarix induced high antibody levels and more robust immune memory response when formulated with its proprietary AS04 adjuvant system, aluminum hydroxide plus MPL (monophosphoryl lipid A), than with aluminum hydroxide alone. GSK is looking to position Cervarix as superior to Merck's HPV vaccine Gardasil, which is formulated with aluminum hydroxide. Gardasil has been on the market since June, also under a priority review (1Pharmaceutical Approvals Monthly June 2006, p. 7)...