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Acadi blockbuster dementia drug Nuplazid rejected by FDA

 Last Update: 2021-05-02
 Source: Internet
 Author: User

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CompileKe Ke

Just a few weeks after the U.

The CRL of the US FDA pointed out that Nuplazid lacks statistical significance in some dementia subgroups, claiming that not enough patients with dementia subtypes have shown effectiveness and did not raise safety issues.

And Acadia pointed out that they had previously reached an agreement with the psychiatric research department supervised by Billy Dunn on the design of the drug’s key phase 3 clinical study HARMONY, which is aimed at analyzing as a single group A broad population of DRP patients.

Some people have speculated that the US FDA will become tougher and tougher on approval this year, and the rejection of this application seems to support this argument.

Acadia’s press release hinted that the company was dissatisfied with the decision.

Acadia CEO Steve Davis stated: "Acadia supports the key Phase 3 study HARMONY and the prospectively agreed trial design, and at the same time supports the establishment of strong and positive results in the establishment of DRP efficacy standards.

Paul Mattis, an analyst at Stifel, an asset management and investment banking company, wrote in a report to investors: "The efficacy of pimavanserin in the relapse prevention trial is the most robust among the Parkinsonian population.

The US FDA stated in its CRL that Acadia's Phase 2 clinical Alzheimer's Psychiatric Study-019 used to support sNDA was not adequately and well controlled.

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Acadia preps for battle as the FDA rejects a potential blockbuster application

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