Progress Made Toward the Approval of Treatment of Agitation Associated With Alzheimer Dementia

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A Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee of the US Food and Drug Administration (FDA) was held to discuss the supplemental New Drug Application (sNDA) of Rexulti (brexpiprazole) for the treatment of agitation associated with Alzheimer dementia.

Announced by Otsuka Pharmaceutical Development & Commercialization Inc and Lundbeck Pharmaceuticals LLC, the meeting included discussion of the results from 2 positive clinical phase III studies, Study 331-12-283 and Study 331-13-213, which were included in the sNDA. The committee voted 9 to 1 that Otsuka and Lundbeck had provided data sufficient to allow the identification of a population that is experiencing greater benefit than risk when being treated with Rexulti for agitation associated with Alzheimer dementia.¹

“We are thankful to the FDA and committee members for the thoughtful review and discussion of Rexulti for the treatment of agitation associated with Alzheimer’s dementia,” said John Kraus, MD, PhD, executive vice president and chief medical officer at Otsuka, in a press release. “We will continue to work closely with the FDA in advance of our scheduled [Prescription Drug User Fee Act] (PDUFA) date and feel confident in the impact Rexulti could have in addressing the significant unmet need within the Alzheimer’s community.”

If approved, Rexulti will be the first FDA-approved treatment for agitation associated with Alzheimer dementia in the United States. The FDA will consider the committee’s feedback as it reviews the sNDA prior to the PDUFA target action date of May 10, 2023.¹

Reference

1. Otsuka and Lundbeck issue statement on U.S. Food and Drug Administration (FDA) advisory committee meeting on REXULTI® (brexpiprazole) for the treatment of agitation associated with Alzheimer’s dementia. Otsuka. News release. April 16, 2023. Accessed April 17, 2023. https://otsuka-us.com/news/otsuka-and-lundbeck-issue-statement-us-food-and-drug-administration-fda-advisory-committee