Brexpiprazole (Rexulti) is an antipsychotic drug that was recently fast-tracked for approval by the US Food and Drug Administration (FDA) for treating agitation in elderly dementia patients.
This decision came despite evidence from clinical trials that the drug may not offer significant benefits and may increase the risk of death.
Economic Stakes: At a cost of approximately $1,400 per month, the makers of Rexulti, Otsuka and Lundbeck, project an added $1 billion in annual sales.
Performance in Trials: Clinical trials showed that patients on brexpiprazole had a death rate four times higher than those on a placebo.
On efficacy, the drug achieved only a modest 5.3-point improvement over a placebo on a 174-point scale, well below the 17 points deemed clinically significant.
FDA’s Decision Raising Eyebrows: Some experts, like Professor Lon Schneider from the Keck School of Medicine, believe that the FDA’s current approval standards are weaker than those from 20 years ago.
The fact that the FDA approved brexpiprazole based on weak evidence sets a concerning precedent for future drug approvals, particularly for vulnerable patient groups.
Advisory Committee Vote: Nine out of ten members of the FDA advisory committee felt that there was adequate data to determine a population where the drug’s benefits would outweigh its risks.
However, even among these members, there were reservations about prescribing the drug to patients with mild symptoms.
Ties to Commercial Interests: Some patient advocacy groups that supported the approval of brexpiprazole have financial connections to pharmaceutical companies.
Organizations like LEAD and the Alliance for Aging Research, which endorsed the drug, receive funding from Otsuka and other drug makers.
Marketing and Perception: Investigative journalist Robert Whitaker suggests that Otsuka might market brexpiprazole as safer than other antipsychotics, even if this supposed safety advantage was constructed through the design of their clinical trials.
Potential Conflict with CMS: The approval of brexpiprazole might go against the efforts of the US Centers for Medicare and Medicaid Services (CMS) which has been trying to decrease the off-label use of antipsychotics in care homes.
A spokesperson for CMS expressed concerns about the side effects of antipsychotic drugs, emphasizing their commitment to minimize unnecessary prescriptions in nursing homes.
Implications
The fast-track approval of brexpiprazole raises crucial questions about the FDA’s approval standards and the influence of commercial interests on drug endorsements.
Given the potential risks associated with the drug, there’s a pressing need for transparent communication and collaboration between healthcare providers, patients, and their families to ensure the best patient outcomes.
If you care about dementia, please read studies about Diabetes drug may reduce dementia risk and findings of Vascular dementia: a simple explanation.
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The study was published in The BMJ.
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