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H. Lundbeck A/S

1xbet 카지노 (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) met to discuss the supplemental New Drug Application (sNDA) of REXULTI® (brexpiprazole) for the treatment of agitation associated with Alzheimer's dementia (AAD). The committee voted 9-1 that Otsuka and Lundbeck provided sufficient data to allow the identification of a population in whom the benefits of treating AAD with brexpiprazole outweigh its risks.

If approved, brexpiprazole would be 1xbet 카지노 first FDA-approved treatment indicated for AAD in 1xbet 카지노 U.S. 1xbet 카지노 FDA will consider 1xbet 카지노 feedback from 1xbet 카지노 committee as it reviews 1xbet 카지노 sNDA for brexpiprazole in advance of 1xbet 카지노 May 10 Prescription Drug User Fee Act (PDUFA) target action date.

"We are thankful to 1xbet 카지노 FDA and committee members for 1xbet 카지노 thoughtful review and discussion of brexpiprazole for 1xbet 카지노 treatment of agitation associated with Alzheimer's dementia," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka Pharmaceutical Development & Commercialization, Inc. "We will continue to work closely with 1xbet 카지노 FDA in advance of our scheduled PDUFA date and feel confident in 1xbet 카지노 impact brexpiprazole could have in addressing 1xbet 카지노 significant unmet need within 1xbet 카지노 Alzheimer's community."

1xbet 카지노 sNDA included data from two positive clinical phase III studies that investigated 1xbet 카지노 treatment of brexpiprazole in patients with AAD. Study 331-12-283 demonstrated brexpiprazole 2 mg/day was statistically superior to placebo for 1xbet 카지노 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 카지노 primary efficacy endpoint, 1xbet 카지노 mean change in CMAI Total Score from baseline to Week 12 (p < 0.05).

"Agitation is one of 1xbet 카지노 most complex and stressful aspects of care in patients affected by Alzheimer's dementia," said Johan Luthman, executive vice president, Lundbeck Research & Development. "With no FDA-approved products for AAD, 1xbet 카지노re is an urgent need for a treatment that could lessen 1xbet 카지노 neuropsychiatric symptoms that AAD patients and caregivers struggle with. Having an approved treatment option for AAD could provide hope to people impacted by this debilitating condition."