Rexulti supported by FDA Advisory Committees for Alzheimer’s agitation
Otsuka Pharmaceutical/Lundbeck’s atypical antipsychotic Rexulti (brexpiprazole) has secured the recommendation of two FDA advisory committees - the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee which at their joint meeting voted 9-1 that Otsuka and Lundbeck provided sufficient data to identify an AAD population in whom the benefits of the drug outweigh its risks for its label expansion
This recommendation may lead to brexpiprazole being the first medicine to treat agitation associated with Alzheimer’s dementia (AAD).
The Prescription Drug User Fee Act (PDUFA) target action date for the proposed indication has been set for May 10.
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