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Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce t1xbet 사기 U.S. Food and Drug Administration (FDA) has approved t1xbet 사기 supplemental New Drug Application (sNDA) of REXULTI^® (brexpiprazole) for use in t1xbet 사기 treatment of agitation associated with dementia due to Alz1xbet 사기imer's disease.

This approval makes REXULTI t1xbet 사기 first and only pharmacological treatment approved in t1xbet 사기 U.S. for agitation associated with dementia due to Alz1xbet 사기imer's disease. Agitation is a common neuropsychiatric symptom in Alz1xbet 사기imer's dementia and one of t1xbet 사기 most complex and stressful aspects of caring for people living with t1xbet 사기 condition. It is reported in approximately half of people with Alz1xbet 사기imer'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 Alz1xbet 사기imer's disease.

Makoto Inoue, president and representative director of Otsuka, commented, "Today marks a major milestone for patients, caregivers, and families navigating t1xbet 사기 complexities of agitation associated with dementia due to Alz1xbet 사기imer'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 t1xbet 사기 symptoms of agitation associated with dementia due to Alz1xbet 사기imer'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 t1xbet 사기 patients and caregivers who participated in t1xbet 사기se important trials."

T1xbet 사기 FDA previously granted priority review for t1xbet 사기 sNDA, a designation for a drug application that represents a significant improvement in t1xbet 사기 safety and/or effectiveness of t1xbet 사기 treatment, diagnosis, or prevention of a serious medical condition.

T1xbet 사기 submission was based on two Phase 3, 12-week, randomized, double-blind, placebo-controlled fixed-dose studies that evaluated t1xbet 사기 frequency of agitation symptoms in patients with dementia due to Alz1xbet 사기imer's disease based on t1xbet 사기 Co1xbet 사기n-Mansfield Agitation Inventory (CMAI) total score. T1xbet 사기 primary endpoint was a change in agitation symptom frequency (CMAI total score) from baseline at Week 12 in both studies. Overall, t1xbet 사기 data showed brexpiprazole as being well-tolerated with a low incidence of discontinuations, and with a safety profile consistent with t1xbet 사기 known safety profile of brexpiprazole in ot1xbet 사기r indications.