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Pfizer/Neurocrine indiplon resubmission

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Merck's human papillomavirus vaccine Gardasil shows a higher efficacy rate in adolescents (male and female) aged 10 to 15 than in young women aged 16 to 23, according to a Phase III study presented May 19 at the European Society of Pediatric Infectious Diseases. In the 1,529-patient trial, seroconversion rates in the combined adolescent cohort (506 female, 510 male) were 100% for HPV types 16, 6 and 11, and 99.9% for HPV 18. Results were identical in the 513 16-23-year old women, except for serotype 18, for which Gardasil produced a 99.1% conversion rate. The study comes on the heels of a Phase II trial published in the April issue of Lancet Oncology, in which the quadrivalent vaccine was shown to significantly reduce the combined incidence of persistent HPV 16, 18, 6 or 11 compared to placebo. Merck plans to file a Gardasil BLA in the second half of 2005 (1Pharmaceutical Approvals Monthly May 2005, In Brief)...

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