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Rexulti On Track To Add Claim For Alzheimer’s Dementia Agitation Following US Panel Nod

 
• By Sue Sutter

Nine of 10 advisory committee members voted favorably for an expansion of brexpiprazole’s label, but some said Otsuka/Lundbeck’s atypical antipsychotic may not be appropriate first-line treatment for patients with mild symptoms or for use in individuals with acute, severe agitation.

Path in forest
Rexulti is on a path to becoming the first FDA-approved treatment for agitation associated with Alzheimer's dementia. • Source: Shutterstock

Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S’ atypical antipsychotic Rexulti (brexpiprazole) has a favorable benefit-risk profile for treatment of agitation associated with Alzheimer’s dementia, but it may not be appropriate for patients with mild symptoms or those with severe, acute agitation, members of a US Food and Drug Administration advisory committee said on 14 April.

Nine of 10 members of the Psychopharmacologic Drugs and Peripheral and Central Nervous System Drugs advisory committees voted favorably for...

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