Acadia’s Nuplazid: US FDA Panel Will Focus On Efficacy For Alzheimer’s Disease Psychosis
Agency questions clinical significance of change in primary efficacy endpoint measured in one study and raises doubts about numerous exploratory analyses for a second study aimed at explaining why Alzheimer’s patient subgroup appeared to derive less benefit than other types of dementia patients.
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Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Advisory committee members cited a litany of shortfalls with efficacy data from two existing studies and say a new Phase III trial is needed in a large, ethnically and racially diverse population of Alzheimer’s disease psychosis patients.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.