Neurochem responds to Kiacta "approvable" letter
This article was originally published in Pharmaceutical Approvals Monthly
Neurochem's complete response is based on "complete follow-up" of all 183 Amyloid A amyloidosis patients in the Kiacta (eprodisate) Phase II/III trial, an option that FDA's August 2006 "approvable" letter had said could be "persuasive" in lieu of the one or more clinical trials to provide additional efficacy information and a safety update. The NDA for Kiacta (formerly Fibrillex), completed Feb. 13, has priority status for treatment of the orphan disorder (1Pharmaceutical Approvals Monthly May 2006, p. 3). Neurochem's follow-up analysis found a longer time to progress to dialysis/end-stage renal disease for Kiacta vs. placebo (p=.018) and non-statistically significant longer time to progress to a composite endpoint of dialysis/ESRD or death for Kiacta patients (p=.062)...
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