Acadia hits another Nuplazid roadblock as the FDA doles out CRL and recommends another trial
Despite winning an approval back in 2016, Acadia’s Nuplazid has not had the easiest of paths in its journey to expand into new areas. And late Thursday night, the company put out a press release saying it received more bad news from the FDA.
Regulators rejected Acadia’s application to expand Nuplazid coverage into Alzheimer’s-related psychosis, the biotech said, turning away its supplemental NDA with a CRL. The rejection letter indicated the FDA also recommended that Acadia conduct an additional trial in ADP, Acadia said.
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