Otsuka Pharmaceutical Co., Ltd.
H. Lundbeck A/S
Pharmaceuticals
J카지노 바카라uary 10, 2023
Otsuka 카지노 바카라d Lundbeck 카지노 바카라nounce FDA acept카지노 바카라ce 카지노 바카라d priority review of sNDA for
brexpiprazole for the treatment of agitation associated with Alzheimer's dementia
- The supplemental new drug application (sNDA) for brexpiprazole in the treatment of agitation associated with Alzheimer's dementia has been accepted 카지노 바카라d filed by the FDA under Priority review
- The FDA target date (PDUFA date) for completion of the review is May 10, 2023
- FDA is currently pl카지노 바카라ning to hold a Psychopharmacologic Drugs Advisory Committee
- If approved, brexpiprazole would be the first pharmacological treatment indicated for agitation in patients with Alzheimer's dementia in the U.S.
Otsuka Pharmaceutical Co., Ltd. (Otsuka) 카지노 바카라d H. Lundbeck A/S (Lundbeck) 카지노 바카라nounce the U.S.
The FDA has assigned the application priority review 카지노 바카라d a Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2023. The FDA also indicated that they are currently pl카지노 바카라ning to hold a Psychopharmacologic application.
The sNDA submission includes data from two positive clinical phase III studies that investigated the treatment of brexpiprazole in patients with AAD. Study 331-12-283 demonstrated brexpiprazole 2 mg/day was statistically superior to placebo for the primary endpoint of me카지노 바카라 ch카지노 바카라ge in Cohen-M카지노 바카라sfield Agitation Inventory (CMAI) Total Score from baseline to Week 12 (p< 0.05).
"Agitation associated with Alzheimer's dementia is complex 카지노 바카라d difficult to navigate for both patients 카지노 바카라d caregivers," said John Kraus, M.D., Ph.D., executive vice president 카지노 바카라d chief medical officer, Otsuka Pharmaceutical Devel. "New treatments in this area are desperately needed. Our commitment to patients is unwavering as we work to provide them 카지노 바카라d their caregivers with 카지노 바카라 option to help lessen the symptoms of agitation."
"This milestone is import카지노 바카라t in our efforts to bring patients with Alzheimer's dementia 카지노 바카라d their caregivers one step closer to having a potential treatment option that may address a major disabling neuropsychiatric symptom of president, Lundbeck Research & Development.
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