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GSK resubmits BLA for Cervarix

Executive Summary

Finally responding to a December 2007 "complete response" letter from FDA, GlaxoSmithKline has re-filed its BLA for Cervarix, its vaccine to prevent cervical cancer and pre-cancer related to human papillomavirus types 16 and 18. Cervarix is approved in Europe and is the market leader in the U.K., ahead of Merck's competing vaccine, Gardasil. GSK's new filing, announced March 30, includes final data from the pivotal HPV-008 study - the previous BLA was based upon interim data. Also holding up FDA approval was the fact that the vaccine uses an adjuvant that is new and has a new active ingredient for which the agency had no regulatory framework (1"The Pink Sheet" DAILY, Oct. 22, 2008)
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