Nuplazid Complete Response Letter For Dementia Psychosis Driven By Effectiveness Concerns In Subgroups
Acadia says the US FDA’s view has shifted from what was previously agreed upon for approval of an sNDA for pimavanserin in a broad dementia-related psychosis indication.
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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.
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.
The US FDA’s use of its advisory committees continues to shrink. In 2022, the expert panels appear primarily to serve as a last chance for sponsors to prevent (or overturn) an FDA rejection.