Otsuka Pharmaceutical Development & Commercialization, Inc, and Lundbeck Pharmaceuticals LLC 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 of REXULTI 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 REXULTI outweigh its risks.
If approved, REXULTI would be the first FDA-approved treatment indicated for AAD in the U.S. The FDA will consider the feedback from the committee as it reviews the sNDA for REXULTI in advance of the May 10 Prescription Drug User Fee Act (PDUFA) target action date.
“We are thankful to the FDA and committee members for the thoughtful review and discussion of REXULTI for the treatment of agitation associated with Alzheimer’s dementia,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka. “We will continue to work closely with the FDA in advance of our scheduled PDUFA date and feel confident in the impact REXULTI could have in addressing the significant unmet need within the Alzheimer’s community.”
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The sNDA included data from two positive clinical phase III studies that investigated the treatment of REXULTI in patients with AAD. Study 331-12-283 demonstrated REXULTI 2 mg/day was statistically superior to placebo for the 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 REXULTI 2 and 3 mg/day showed statistically significant improvement compared with placebo for the primary efficacy endpoint, the mean change in CMAI Total Score from baseline to Week 12.
“Agitation is one of the 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, there is an urgent need for a treatment that could lessen the 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.”
SOURCE: Businesswire