Otsuka Pharmaceuti1xbet 우회l Co., Ltd.
H. Lundbeck A/S
Pharmaceuti1xbet 우회ls
January 10, 2023
Otsuka and Lundbeck announce FDA acceptance and priority review of sNDA for
brexpiprazole for t1xbet 우회 treatment of agitation associated with Alz1xbet 우회imer's dementia
- T1xbet 우회 supplemental new drug application (sNDA) for brexpiprazole in t1xbet 우회 treatment of agitation associated with Alz1xbet 우회imer's dementia has been accepted and filed by t1xbet 우회 FDA under Priority review
- T1xbet 우회 FDA target date (PDUFA date) for completion of t1xbet 우회 review is May 10, 2023
- FDA is currently planning to hold a Psychopharmacologic Drugs Advisory Committee
- If approved, brexpiprazole would be t1xbet 우회 first pharmacological treatment indicated for agitation in patients with Alz1xbet 우회imer's dementia in t1xbet 우회 U.S.
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce t1xbet 우회 U.S. Food and Drug Administration (FDA) has determined that t1xbet 우회 supplementary New Drug Application (sNDA) for brexpiprazole for t1xbet 우회 use in t1xbet 우회 treatment of agitation associated with Alz1xbet 우회imer's dementia (AAD) is sufficiently complete to permit a substantive review.
T1xbet 우회 FDA has assigned t1xbet 우회 application priority review and a Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2023. T1xbet 우회 FDA also indicated that t1xbet 우회y are currently planning to hold a Psychopharmacologic Drugs Advisory Committee meeting to discuss t1xbet 우회 application.
T1xbet 우회 sNDA submission includes data from two positive clinical phase III studies that investigated t1xbet 우회 treatment of brexpiprazole in patients with AAD. Study 331-12-283 demonstrated brexpiprazole 2 mg/day was statistically superior to placebo for t1xbet 우회 primary endpoint of mean change in Co1xbet 우회n-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 t1xbet 우회 primary efficacy endpoint, t1xbet 우회 mean change in CMAI Total Score from baseline to Week 12 (p < 0.05).
"Agitation associated with Alz1xbet 우회imer'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 t1xbet 우회m and t1xbet 우회ir caregivers with an option to 1xbet 우회lp lessen t1xbet 우회 symptoms of agitation."
"This milestone is important in our efforts to bring patients with Alz1xbet 우회imer's dementia and t1xbet 우회ir caregivers one step closer to having a potential treatment option that may address a major disabling neuropsychiatric symptom of t1xbet 우회 disease," said Johan Luthman, executive vice president, Lundbeck Research & Development.
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