Otsuka, Lundbeck Receive FDA Approval for New Alzheimer’s Medication

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Rexulti to be first authorized treatment for agitation associated with dementia.

Otsuka Pharmaceutical, a global healthcare company, has received FDA approval for a new dementia drug in association with Lundbeck, a pharmaceutical organization specializing in brain diseases. As the first of its kind to be authorized, Rexulti focuses on combating agitation for those with Alzheimer’s disease.


Previously, the FDA granted Rexulti priority review, designating it a significant improvement in the effectiveness of a treatment.

“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,” said Deborah Dunsire, CEO, president, Lundbeck. “We look forward to offering this first FDA-approved treatment option to address this significant unmet need for patients.”