At Last: Acadia Submits NDA, Makes Davis Permanent CEO
This article was originally published in Scrip
Following delay after delay, Acadia Pharmaceuticals finally submitted a new drug application (NDA) to the US FDA seeking approval for Nuplazid (pimavanserin) nearly three years after the company reported positive Phase III results in the treatment of Parkinson's disease psychosis (PDP).
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After accelerated approval in the US in April based on Phase II response rates, the company will seek full approval later this year based on a tripling of progression-free survival in a Phase III trial.
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