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GSK Cervarix gets standard review

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

GlaxoSmithKline's BLA for Cervarix gets 10-month standard review, setting a January 2008 user fee date for the human papilloma virus vaccine. The firm submitted the vaccine March 29 with a request for a priority review (1Pharmaceutical Approvals Monthly April 2007, In Brief). The decision gives Merck additional time to establish Gardasil, which launched in June 2006, as the only vaccine on the market to prevent human papilloma virus infection and associated diseases, such as cervical cancer. GSK hopes to position Cervarix as a superior product; a head-to-head trial comparing Cervarix to Gardasil is ongoing (2Pharmaceutical Approvals Monthly February 2007, p. 21). In April, Merck submitted an sBLA seeking additional claims for Gardasil for protection against vaginal and vulvar cancers...

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GSK’s Cervarix reaches FDA

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)...

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