An article in The BMJ is sounding the alarm that the US Food and Drug Administration fast-tracked approval for the dementia drug Rexulti (brexpiprazole) — even though trials show the drug is harmful.
Brexpiprazole is an antipsychotic medication to treat agitation in elderly patients with dementia. It’s approved for agitation linked to dementia that’s a result of Alzheimer’s disease.
“The small benefits do not outweigh serious safety concerns,” Nina Zeldes, public citizen health researcher, told the FDA’s Advisory Committee prior to the approval in May. “Like other antipsychotics, this is a drug that can kill patients without providing a meaningful benefit.”
The drug made by Otsuka and Lundbeck costs about $1,400 per month. The companies are expected to make an additional $1 billion in annual sales with the extension for it to be used in this subset of people [it’s already approved for other uses], according to Robert Whitaker, an investigative journalist who penned the report in The BMJ on Aug. 17.
The decision to approve the drug may reverse efforts by the Centers for Medicare & Medicaid Services to reduce the widespread off-label use of antipsychotics in residential care homes, Whitaker said.
The drug comes with a “boxed warning,” which is the FDA’s most serious type of warning. The warning says taking the drug increases the user’s chances of death. In three pre-approval trials, the death rate was four times higher in those given brexpiprazole compared to those given placebo.
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. Outcomes from the trials were similar to earlier trials of other antipsychotics used in Alzheimer’s patients, yet none of these other antipsychotics were approved for treating behavioral symptoms in older people with dementia, Whitaker wrote. Whitaker cited previous comments from Lon Schneider, MD, a professor of psychiatry, neurology, and gerontology at the Keck School of Medicine at the University of Southern California.
“We are very disappointed that the FDA approved this additional label indication for brexpiprazole on such weak data,” Zeldes said. “The FDA has set a dangerous precedent about the data it may require for future drug approvals for this vulnerable patient group.”
According to a press release from The BMJ, the FDA would not respond for comment.
