FDA Advisory Committee Recommends Rexulti for Alzheimer’s-Related Agitation

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Agitation is a common symptom of Alzheimer’s disease, negatively impacting the quality of life for patients and their caregivers. An advisory committee for the US Food and Drug Administration (FDA) has given the nod to expand the indication of Takeda and Lundbeck’s Rexulti, a widely used atypical antipsychotic, to include the treatment Alzheimer’s disease-related agitation (AAD).

According to Phil Taylor, “The new application included data from two phase 3 trials – codenamed 331-12-283 and 331-14-213 – which found that Rexulti was more effective than placebo at improving scores on the Cohen-Mansfield Agitation Inventory (CMAI) scale over 12 weeks of follow up. The CMAI is a caregivers’ rating scale focusing 29 agitation symptoms, each rated on a seven-point scale of frequency, and covers physically aggressive, physically non-aggressive, and verbally agitated behaviours. Behavioural and psychological symptoms are estimated to affect up to 90% of people living with dementia.”

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(Source: PharmaPhorum, April 18^th, 2023)