Briefing docs for Acadia's Alzheimer's-related psychosis resubmission reveal an undecided FDA
In its quest to resubmit its Alzheimer’s-induced psychosis drug Nuplazid to the FDA following a CRL, Acadia Pharmaceuticals will have to face an advisory committee later this week. And agency officials released their briefing documents ahead of the hearing Wednesday, revealing a mixed bag of opinions.
FDA statisticians found that the data supporting Acadia’s resubmission, which comprises several post-hoc analyses of its previous pivotal trial, did not appear to conclude the drug is effective in Alzheimer’s patients. But Acadia also repositioned an earlier study as the primary focus of the application, and regulators seemed open to considering this new approach.
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