In trials, the antipsychotic drug brexpiprazole (Rexulti) failed to provide a clinically meaningful benefit and increased the risk of death. Yet the US Food and Drug Administration (FDA) has fast tracked its approval, making Rexulti the first antipsychotic for treating agitation in elderly patients with dementia.
At a cost of around $1,400 a month Rexulti's makers, Otsuka and Lundbeck, are forecasting an additional $1 billion in annual sales, but there are serious questions about the harm-benefit balance of this drug, writes investigative journalist Robert Whitaker in The BMJ today.
On efficacy, the drug showed a maximum 5.3-point improvement over placebo on a 174-point scale, far short of the 17 points considered to be clinically important. Schneider says the FDA has a "lower standard of approval" today than it did 20 years ago, a theme echoed by Zeldes, who said: "We are very disappointed that the FDA approved this additional label indication for brexpiprazole on such weak data. The FDA has set a dangerous precedent about the data it may require for future drug approvals for this vulnerable patient group."
Whitaker notes that a number of patient advocacy groups, such as the Alliance for Aging Research, Leaders Engage on Alzheimer's Research , and Us Against Alzheimer's, urged the FDA to approve brexpiprazole.
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Alarm as FDA fast-tracks first antipsychotic drug for agitation in dementiaIn trials, the antipsychotic drug brexpiprazole (Rexulti) failed to provide a clinically meaningful benefit and increased the risk of death. Yet the US Food and Drug Administration (FDA) has fast tracked its approval, making Rexulti the first antipsychotic for treating agitation in elderly patients with dementia.
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