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Otsuka/Lundbeck’s Rexulti Has Time To Build A Lead In The Alzheimer’s Agitation Market

 
• By Alaric DeArment

The US FDA approved Rexulti as the first drug for agitation in Alzheimer’s disease, a multibillion-dollar market where Lundbeck estimates it could bring in $1bn in annual sales.

Otsuka/Lundbeck received approval for Rexulti in AAD • Source: Shutterstock

Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S have a definitive first-mover advantage with Rexulti (brexpiprazole) becoming the first drug to receive US Food and Drug Administration approval for agitation associated with dementia due to Alzheimer’s disease (AAD). They face potential competition in the form of Axsome Therapeutics, Inc.’s AXS-05 (dextromethorphan-bupropion), but with that drug’s Phase III study expected to complete in the first half of next year, Otsuka/Lundbeck have time to establish Rexulti.

The FDA cleared Rexulti for AAD on 10 May, shortly after Lundbeck announced its first quarter 2023 earnings

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