Merck Gardasil BLA a priority?
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Merck is requesting a priority review for its human papillomavirus vaccine Gardasil (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant), submitted Dec. 1. If granted a priority review, a June 1, 2006 approval would allow Merck to launch the vaccine before the 2006 back-to-school immunization season. GlaxoSmithKline continues development of its HPV vaccine Cervarix, which it claims offers viral protection against multiple viral strains and in a wider age group than Gardasil (Pharmaceutical Approvals Monthly July 2005, p. 4). GSK said it plans to submit Cervarix in 2006...