Merck Gardasil BLA by year end
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Merck plans to submit a BLA for its human papilloma virus vaccine Gardasil by the end of 2005 following release of the first Phase III results Oct. 6. Primary analysis of the FUTURE II trial found 100% efficacy against HPV types 16- and 18-related cervical pre-cancers (cervical intraepithelial neoplasia grades 2 and 3) and non-invasive cancers (adenocarcinoma in situ) in women ages 16 to 26 receiving a three-vaccine series. The vaccine was 97% effective in a secondary analysis that included women who violated protocol. GlaxoSmithKline maintains that viral cross-protection will be a key factor differentiating its competing HPV vaccine Cervarix (1Pharmaceutical Approvals Monthly July 2005, p. 4). Unlike Gardasil, which includes HPV strains 6, 11, 16 & 18, Cervarix includes only high-risk strains 16 and 18...
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