Otsuka Pharmaceutical and H Lundbeck have received approval for the supplemental new drug application (sNDA) from the US Food and Drug Administration for Rexulti (brexpiprazole) to treat agitation associated with dementia due to Alzheimer’s disease.

Rexulti has become the first and only pharmacological treatment to receive approval for this indication in the US.

The regulator accepted and granted priority review for the sNDA in January 2023.

Otsuka Pharmaceutical representative director and president Makoto Inoue stated: “Today marks a major milestone for patients, caregivers and families navigating the complexities of agitation associated with dementia due to Alzheimer’s disease.

“Otsuka Pharmaceutical will continue its efforts to engage and provide options for those impacted by this devastating condition.”

The submission of sNDA was based on the data obtained from two placebo-controlled, double-blind, fixed-dose, randomised 12-week Phase III trials.

The trials assessed the frequency of agitation symptoms in Alzheimer’s dementia patients, based on the Cohen-Mansfield agitation inventory (CMAI) total score.

The change in agitation symptom frequency from baseline at week 12 was the primary endpoint of the two trials.

Brexpiprazole was found to be well-tolerated and its safety profile was consistent with its known safety profile in other indications.

Lundbeck president and CEO Deborah Dunsire stated: “This approval is a testament to our commitment and unwavering support of patients and caregivers to lessen the symptoms of agitation associated with dementia due to Alzheimer’s disease.

“We look forward to offering this first FDA-approved treatment option to address this significant unmet need for patients.”