Monday June 30, 05:56 PM
GSK's Cervarix could face further delay
LONDON (ShareCast) - Drug maker GlaxoSmithKline (LSE: GSK.L - news) could see its cancer vaccine Cervarix face a further delay in getting
US approval after it said it will submit new data on the drug in the first half of 2009."Given that final data from GSK's Phase III pivotal efficacy study, HPV-008, are expected to be available later this year, GSK has decided to augment its application for approval with these data to ensure they are included in the U.S. label. GSK anticipates submitting these data in the first half of 2009," it said. The group said the timing of the submission depends on it reaching a certain number of cases in order to conduct the final analysis. "An FDA action on the application is expected to take up to six months following this submission," said GSK. "The company does not expect that new clinical studies will be required for approval," it added. Interim data on the study was initially filed in the original application for the vaccine in March 2007.
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