FDA’s Shocking Approval: Rexulti Fast-Tracked Despite Deadly Risks

by François Dupont
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The FDA’s Startling Approval: Rexulti Expedited Despite Lethal Risks

In a controversial move that raises serious concerns about the FDA’s current approval standards and the influence of commercial interests on patient advocacy groups, the US Food and Drug Administration (FDA) has fast-tracked the approval of the antipsychotic drug brexpiprazole (Rexulti) for elderly dementia patients, despite its increased risk of death and limited clinical benefits.

This decision to expedite Rexulti’s approval, which may potentially boost profits for drug companies Otsuka and Lundbeck, is now the subject of investigation and has cast doubt on the careful balance between the benefits and harms associated with the drug. It could also undo years of efforts by the US Centers for Medicare and Medicaid Services (CMS) to reduce the widespread off-label use of antipsychotics in residential care homes.

During clinical testing, brexpiprazole (Rexulti) failed to demonstrate significant therapeutic effects and was linked to a higher mortality risk. Shockingly, Rexulti has become the first antipsychotic approved for treating agitation in elderly dementia patients, despite these concerning findings.

With a monthly cost of approximately $1,400, Rexulti’s manufacturers are anticipating an additional $1 billion in annual sales. However, this potential financial gain is overshadowed by questions regarding the drug’s harm-benefit ratio, as noted by investigative journalist Robert Whitaker in a recent article published in The BMJ.

The FDA has assigned a “boxed warning,” its most serious type of warning, to Rexulti, highlighting an elevated risk of death associated with the drug. Furthermore, in three pre-approval trials, it was found that the death rate among those administered brexpiprazole was four times higher compared to those who received a placebo.

In terms of efficacy, Rexulti showed a mere 5.3-point improvement over placebo on a 174-point scale, falling far short of the 17 points considered clinically significant.

Public Citizen health researcher Nina Zeldes expressed concerns, stating, “The minimal benefits do not outweigh the serious safety concerns. Like other antipsychotics, this is a drug that can harm patients without providing a meaningful benefit.”

Professor Lon Schneider at the Keck School of Medicine of the University of Southern California pointed out that the outcomes of brexpiprazole closely mirrored those of earlier trials involving antipsychotics in Alzheimer’s patients. However, none of these antipsychotics had previously been approved for treating behavioral symptoms in elderly dementia patients.

There is a consensus among experts that the FDA’s standards for approval have lowered over the past two decades, a sentiment echoed by Zeldes, who expressed disappointment in the FDA’s decision to approve brexpiprazole based on weak data.

In a vote, nine out of ten members of the FDA committee believed that there was sufficient data to identify a population in which the benefits of Rexulti outweighed its risks. Nevertheless, even those in favor expressed concerns about its use in patients with mild symptoms, emphasizing the need for personalized risk-benefit assessments in collaboration with patients’ families.

The chair of the advisory committee, Rajesh Narendran, declined interviews, and the FDA’s Center for Drug Evaluation and Research cited conflicting schedules and competing priorities as reasons for not responding to inquiries.

Whitaker also noted that several patient advocacy groups, such as the Alliance for Aging Research, Leaders Engage on Alzheimer’s Research (LEAD), and Us Against Alzheimer’s, advocated for Rexulti’s approval. However, this support may be influenced by commercial interests, as LEAD counts Otsuka and other pharmaceutical companies among its members, and the Alliance for Aging Research receives funding from Otsuka and other pharmaceutical companies.

Erick Turner, a former FDA reviewer and psychiatry professor, predicted that clinicians’ responses to the approval would depend on their existing beliefs about prescribing antipsychotics to Alzheimer’s patients. Marketing efforts, he suggested, would likely rely on key opinion leaders (KOLs) and drug representatives to “educate” clinicians.

It remains to be seen how these marketing efforts will align with the ongoing initiatives by CMS to reduce the unnecessary prescription of antipsychotics in nursing homes, given the potentially severe side effects, including death, associated with these medications.

Frequently Asked Questions (FAQs) about FDA Approval

What is the FDA’s decision regarding Rexulti?

The FDA fast-tracked the approval of Rexulti, an antipsychotic drug for elderly dementia patients, despite concerns about its safety and limited clinical benefits.

Why is this decision controversial?

The decision is controversial because Rexulti was associated with a heightened mortality risk during clinical testing, and its therapeutic effects were minimal. This approval has raised questions about the FDA’s approval standards and the influence of commercial interests.

What are the financial implications of this approval?

Rexulti’s manufacturers, Otsuka and Lundbeck, anticipate approximately $1 billion in annual sales, but there are concerns about the drug’s harm-benefit balance given its safety profile and efficacy.

How does Rexulti compare to other antipsychotic drugs?

Like other antipsychotics, Rexulti carries a “boxed warning” from the FDA regarding an increased risk of death. It showed only a modest improvement over a placebo on a clinical scale, falling far short of the clinically significant threshold.

What are experts saying about this approval?

Experts have expressed disappointment in the FDA’s decision, citing a lower standard of approval compared to two decades ago. Some argue that the benefits of Rexulti do not outweigh the serious safety concerns it presents.

What is the role of patient advocacy groups in this situation?

Several patient advocacy groups supported Rexulti’s approval, but it’s noted that some of these groups have ties to pharmaceutical companies, raising questions about the influence of commercial interests.

How might clinicians respond to this approval?

Clinicians’ responses are expected to vary based on their existing beliefs about prescribing antipsychotics to Alzheimer’s patients. Marketing efforts are likely to involve key opinion leaders (KOLs) and drug representatives.

What is the stance of the CMS regarding antipsychotic use in nursing homes?

The CMS continues its efforts to reduce the prescription of unnecessary antipsychotics in nursing homes due to the potentially severe side effects, including death, associated with these medications.

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