FDA panel says benefits outweigh risks for Acadia's Parkinson's drug
- Acadia Pharmaceutical's Parkinson's psychosis drug on Tuesday won the support of a FDA advisory committee, which voted 12-2 that the drug's benefits outweighed the risks, the company said.
- In a phase 3 trial, Nuplazid showed efficacy in treating Parkinsion's disease psychosis (PDP) but had a higher associated risk of adverse events compared to a placebo. There is currently no drug approved to specifically treat PDP, which affects about 40% of patients worldwide.
- Winning the backing of the advisory committee gives Nuplazid's prospects for approval a major boost. Although the FDA doesn't always follow the advice of the committee, a supportive vote has substantial influence. A final decision is scheduled for May 1.
Nuplazid would meet a currently unmet medical need, as patients suffering from PDP have no treatment specifically approved for their condition. Treating practitioners have typically prescribed antipsychotics or atypicals, which have other side effects.
In a phase 3 clinical trial, Nuplazid showed efficacy in PDP based on changes in the nine-item SAPS-PD scale, which has been modified from a scale originally developed for schizophrenia. However, in the six-week trial, 7.9% of subjects treated with Nuplazid experienced severe adverse events, compared with 3.5% of placebo-treated subjects.
These safety concerns may prompt the FDA to approve Nuplazid with a black box warning, its highest warning.
“We are very encouraged by the Committee’s positive vote today and look forward to working with the FDA as it completes its review of Nuplazid. If approved by the FDA, NUPLAZID would be the first drug indicated to treat psychosis associated with Parkinson’s disease,” said Acadia CEO Steve Davis in a statement on the vote.
The FDA has already granted Nuplazid priority review, as well as designating the drug a breakthough therapy.
Shares of Acadia jumped higher in after hours trading. Analysts have forecast $1.4 billion in 2020 sales for the drug. With the support of the advisory committee in hand, Acadia just took a major step towards realizing that blockbuster potential.
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