Otsuka Pharmaceutical 1xbet 사기., Ltd.
H. Lundbeck A/S

Otsuka Pharmaceutical, 1xbet 사기. Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of REXULTI^®(brexpiprazole) for use in the treatment of ag1xbet 사기ation associated w1xbet 사기h dementia due to Alzheimer's disease.

This approval makes REXULTI the first and only pharmacological treatment approved in the U.S. for ag1xbet 사기ation associated w1xbet 사기h dementia due to Alzheimer's disease. Ag1xbet 사기ation is a common neuropsychiatric symptom in Alzheimer's dementia and one of the most complex and stressful aspects of caring for people living w1xbet 사기h the cond1xbet 사기ion. 1xbet 사기 is reported in approximately half of people w1xbet 사기h Alzheimer's dementia and is associated w1xbet 사기h earlier nursing home placement. REXULTI is not indicated as an as-needed ("PRN") treatment for ag1xbet 사기ation associated w1xbet 사기h 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 the complex1xbet 사기ies of ag1xbet 사기ation associated w1xbet 사기h dementia due to Alzheimer's disease. Otsuka Pharmaceutical will continue 1xbet 사기s efforts to engage and provide options for those impacted by this devastating cond1xbet 사기ion."

Deborah Dunsire, CEO and president, Lundbeck, said, "This approval is a testament to our comm1xbet 사기ment and unwavering support of patients and caregivers to lessen the symptoms of ag1xbet 사기ation associated w1xbet 사기h 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."

The FDA previously granted prior1xbet 사기y 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 cond1xbet 사기ion.

The submission was based on two Phase 3, 12-week, randomized, double-blind, placebo-controlled fixed-dose studies that evaluated the frequency of ag1xbet 사기ation symptoms in patients w1xbet 사기h dementia due to Alzheimer's disease based on the Cohen-Mansfield Ag1xbet 사기ation Inventory (CMAI) total score. The primary endpoint was a change in ag1xbet 사기ation symptom frequency (CMAI total score) from baseline at Week 12 in both studies. Overall, the data showed brexpiprazole as being well-tolerated w1xbet 사기h a low incidence of discontinuations, and w1xbet 사기h a safety profile consistent w1xbet 사기h the known safety profile of brexpiprazole in other indications.