Otsuka and Lundbeck gain FDA approval for supplemental New Drug Application for dementia drug

James Spargo | May 11, 2023 | News story | Medical Communications FDA, Lundbeck, Neurology, Otsuka Pharmaceuticals, alzheimer's disease, dementia 

Japan-based healthcare company Otsuka Pharmaceutical and Danish pharma company Lundbeck have announced that the US Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for their agitation associated with dementia due to Alzheimer’s disease drug.

Rexulti (brexpiprazole) is mediated through a partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. It was previously approved in the US as an adjunctive therapy to antidepressants in adults with Major Depressive Disorder (MDD) and as a treatment for schizophrenia in adults in 2015, and by the European Medicines Agency (EMA) for the treatment of schizophrenia in 2018.

The companies’ submission to the FDA was based on two phase 3, 12-week, randomised, double blind, placebo-controlled, fixed-dose studies. These evaluated the frequency of agitation symptoms in patients with dementia due to Alzheimer’s disease based on the Cohen-Mansfield Agitation Inventory (CMAI) total score.

The primary endpoint ‒ a change in CMAI total score from baseline ‒ was achieved, with a 31% greater reduction from baseline versus placebo.

Makoto Inoue, president and representative director of Otsuka, commented: “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.”

Deborah Dunsire, CEO and president of Lundbeck, said, “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. We are grateful to the patients and caregivers who participated in these important trials.”

James Spargo

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