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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 an expansion of brexpiprazole’s label to include agitation associated with Alzheimer’s dementia, putting it on track to become the first approved medication for AAD by its May user fee deadline

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