Princeton-based Otsuka Pharmaceutical announced Thursday that the Food & Drug Administration has approved the supplemental New Drug Application (better known as an sNDA) of Rexulti for use in the treatment of agitation associated with dementia due to Alzheimer’s disease.
The drug was created in partnership with Deerfield, Illinois-based Lundbeck.
The approval makes Rexulti the first and only pharmacological treatment approved in the U.S. for agitation associated with dementia due to Alzheimer’s disease.
Agitation is a common neuropsychiatric symptom in Alzheimer’s dementia and one of the most complex and stressful aspects of caring for people living with the condition. It is reported in approximately half of people with Alzheimer’s dementia and is associated with earlier nursing home placement.
Otsuka President Makoto Inoue said the approval will have great impact.
“Today marks a major milestone for patients, caregivers and families navigating the complexities of agitation associated with dementia due to Alzheimer’s disease,” he said. “Otsuka Pharmaceutical will continue its efforts to engage and provide options for those impacted by this devastating condition.”
Lundbeck CEO Deborah Dunsire was equally pleased.
“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,” she said. “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.”
The FDA previously granted priority review for the sNDA, a designation for a drug application that represents a significant improvement in the safety and/or effectiveness of the treatment, diagnosis or prevention of a serious medical condition.