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Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce 1xbet 사기 U.S. Food and Drug Administration (FDA) has approved 1xbet 사기 supplemental New Drug Application (sNDA) of REXULTI^®(brexpiprazole) for use in 1xbet 사기 treatment of agitation associated with dementia due to Alzheimer's disease.

This approval makes REXULTI 1xbet 사기 first and only pharmacological treatment approved in 1xbet 사기 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 1xbet 사기 most complex and stressful aspects of caring for people living with 1xbet 사기 condition. It is reported in approximately half of people with Alzheimer's dementia and is associated with earlier nursing home placement. REXULTI is not indicated as an as-needed ("PRN") treatment for agitation associated with dementia due to Alzheimer's disease.

Makoto Inoue, president and representative director of Otsuka, commented, "Today marks a major milestone for patients, caregivers, and families navigating 1xbet 사기 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, Lundbeck, said, "This approval is a testament to our commitment and unwavering support of patients and caregivers to lessen 1xbet 사기 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 1xbet 사기 patients and caregivers who participated in 1xbet 사기se important trials."

1xbet 사기 FDA previously granted priority review for 1xbet 사기 sNDA,a designation for a drug application that represents a significant improvement in 1xbet 사기 safety and/or effectiveness of 1xbet 사기 treatment, diagnosis, or prevention of a serious medical condition.

1xbet 사기 submission was based on two Phase 3, 12-week, randomized, double-blind, placebo-controlled fixed-dose studies that evaluated 1xbet 사기 frequency of agitation symptoms in patients with dementia due to Alzheimer's disease based on 1xbet 사기 Cohen-Mansfield Agitation Inventory (CMAI) total score. 1xbet 사기 primary endpoint was a change in agitation symptom frequency (CMAI total score) from baseline at Week 12 in both studies. Overall, 1xbet 사기 data showed brexpiprazole as being well-tolerated with a low incidence of discontinuations, and with a safety profile consistent with 1xbet 사기 known safety profile of brexpiprazole in o1xbet 사기r indications.