Brexpiprazole, marketed as Rexulti, was granted supplemental approval on May 11 by the US Food and Drug Administration (FDA) for treating agitation linked with Alzheimer disease, the most common cause of dementia. Approval for the drug is based on results from 2 phase 3 randomized clinical trials that showed “statistically significant and clinically meaningful improvements” in caregiver-reported agitation symptoms for patients receiving 2 or 3 mg of brexpiprazole compared with those receiving a placebo, according to the FDA’s statement.
FDA Greenlights First Drug for Agitation Related to Alzheimer Disease
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Giugno 2023
