- The FDA fast-tracked approval for an antipsychotic drug, brexpiprazole, to treat agitation in elderly patients with dementia.
- However, the medication produced clinically insignificant improvements in clinical trials and increased risk of death by four times compared to a placebo.
- Medical News Today spoke with experts in the field to learn more about the drug and the FDA’s decision.
The FDA has
While advocacy groups such as the Alzheimer’s Association have supported the news, others have been more skeptical. Investigative journalist Robert Whitiker, for example, wrote a feature in the
He noted that the first two placebo-controlled
He also wrote that the risk of death among those taking brexpiprazole was
Medical News Today talked with various medical doctors, an FDA spokesperson, and the Alzheimer’s Association to understand more about brexpiprazole’s potential for treating those with dementia.
MNT began by asking a spokesperson from the FDA why they fast-tracked the drug’s approval. He said that brexpiprazole was fast-tracked to meet an unmet medical need and that it is the first FDA-approved drug to treat dementia-related agitation.
“[Fast-track programs intend] to help ensure that therapies for serious conditions are approved and available to patients as soon as it can be…
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