Thursday, March 28, 2024
HomeHealthcareFDA rejects Acadia Pharma's Alzheimer's drug; new trial needed

FDA rejects Acadia Pharma’s Alzheimer’s drug; new trial needed


FDA for second time in 16 months reject Acadia Pharmaceuticals is trying to expand the approval of its antipsychotic drug, this time to treat the psychosis experienced by Alzheimer’s patients.

The Acadia drug Nuplazid was originally approved to treat psychosis in people with Parkinson’s disease. The drug is the only approved product from the San Diego-based biotech. Acadia has been trying to expand the use of the drug to treat psychosis caused by other neurological disorders. In its latest rejection announcement, the company said the FDA recommended that the company conduct another clinical trial in Alzheimer’s.

When Acadia tried to expand Nuplazid’s approval to include dementia-related psychosis last year, the FDA was wary of Alzheimer’s data. In addition to data from this group of patients, the company’s filing includes results from two other placebo-controlled studies: a Phase 2 trial in Alzheimer’s patients and a Phase 3 study in Parkinson’s patients.

April 2021, FDA rejects Nuplazid’s application for dementia-related psychosisRegulators told Arcadia that these subgroups lacked evidence of the drug’s efficacy. The agency also flagged Alzheimer’s subgroups, telling the company that the study, which was conducted at a single site, was insufficient and not well controlled. The agency also recommended that the company preferably conduct additional clinical studies in each subgroup of patients seeking additional approvals.

Arcadia has not conducted additional clinical studies. In February, the company refiled its Nuplazid application and conducted additional analysis of the data it had. In addition to responding to the rejected dementia-related psychosis application, the company is also seeking additional approval for Alzheimer’s disease psychosis.

The complete response letter is not a public document. According to Acadia, the FDA letter said that while the Alzheimer’s study showed a statistically significant treatment effect, there are “limitations” in the interpretability of the study’s findings. The agency also told the company that the drug’s positive role in studies of dementia-related psychosis appears to be driven by positive results in the Parkinson’s dementia subgroup, which is now included in the drug’s approval for Parkinson’s patients.

“We are disappointed with this result,” Chief Executive Steve Davis said in a prepared statement. “The treatment of Alzheimer’s disease psychosis remains an area of ​​high unmet need, with no approved treatments.”

Nuplazid is a small molecule designed to target 5-HT2A receptors, which are thought to play a role in neuropsychiatric disorders. Approved in 2016, the drug covers the treatment of hallucinations and delusions associated with Parkinson’s psychosis.

In 2021, Nuplazid’s sales will be $484.1 million, according to Acadia’s financial report. In the first quarter of this year, the company reported sales of $115.4 million, up 8.3% from the same period in 2021. The company is working to expand its portfolio beyond its flagship drug.Last month, it submitted a New Drug Application for Trefinatea drug developed for Rett syndrome, a rare inherited neurodevelopmental disorder for which there is no FDA-approved treatment.

Arcadia is Scheduled Second-quarter financial results are released after the market close on Monday.

Photo: SIphotography, Getty Images



Source link

RELATED ARTICLES

Most Popular

Recent Comments