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BioWorld - Thursday, May 14, 2026
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Home » Taking inventory of CMAI, adcom briefing docs add up to favor Otsuka/Lundbeck’s Rexulti in AD agitation
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Taking inventory of CMAI, adcom briefing docs add up to favor Otsuka/Lundbeck’s Rexulti in AD agitation

April 12, 2023
By Randy Osborne
Briefing documents suggest smooth sailing for Rexulti (brexpiprazole) at the meeting to deliberate an application to expand the label of the compound from Otsuka Pharmaceutical Co. Ltd. and Lundbeck A/S into agitation related to Alzheimer’s disease (AD) dementia. A joint sit-down on April 14 of the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee (adcom) and the Peripheral and Central Nervous System Drugs Advisory Committee will take up the matter of an add-on indication for Rexulti, a serotonin-dopamine activity modulator for schizophrenia and for the adjunctive treatment of major depressive disorder.
BioWorld Regulatory Neurology/psychiatric FDA

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