1xbet 우회 Pharmaceutical Co., Ltd.
H. Lundbeck A/S

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce 1xbet 우회 U.S. Food and Drug Administration (FDA) has determined that 1xbet 우회 supplementary New Drug Application (sNDA) for brexpiprazole for 1xbet 우회 use in 1xbet 우회 treatment of agitation associated with Alzheimer's dementia (AAD) is sufficiently complete to permit a substantive review.

1xbet 우회 FDA has assigned 1xbet 우회 application priority review and a Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2023. 1xbet 우회 FDA also indicated that 1xbet 우회y are currently planning to hold a Psychopharmacologic Drugs Advisory Committee meeting to discuss 1xbet 우회 application.

1xbet 우회 sNDA submission includes data from two positive clinical phase III studies that investigated 1xbet 우회 treatment of brexpiprazole in patients with AAD. Study 331-12-283 demonstrated brexpiprazole 2 mg/day was statistically superior to placebo for 1xbet 우회 primary endpoint of mean change in Cohen-Mansfield Agitation Inventory (CMAI) Total Score from baseline to Week 12 (p < 0.05). In Study 331-14-213, treatment with brexpiprazole 2 and 3 mg/day showed statistically significant improvement compared with placebo for 1xbet 우회 primary efficacy endpoint, 1xbet 우회 mean change in CMAI Total Score from baseline to Week 12 (p < 0.05).

"Agitation associated with Alzheimer's dementia is complex and difficult to navigate for both patients and caregivers," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "New treatments in this area are desperately needed. Our commitment to patients is unwavering as we work to provide 1xbet 우회m and 1xbet 우회ir caregivers with an option to help lessen 1xbet 우회 symptoms of agitation."

"This milestone is important in our efforts to bring patients with Alzheimer's dementia and 1xbet 우회ir caregivers one step closer to having a potential treatment option that may address a major disabling neuropsychiatric symptom of 1xbet 우회 disease," said Johan Luthman, executive vice president, Lundbeck Research & Development.