The U.S. Food and Drug Administration announced the supplemental approval of Rexulti (brexpiprazole) oral tablets to treat agitation associated with dementia due to Alzheimer's disease. This is the first FDA-approved treatment option for this indication.
The supplemental approval of Rexulti was granted to Otsuka Pharmaceutical Co. Ltd., and Lundbeck Inc. Rexulti was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck.
Dementia is a serious and debilitating neurological condition characterized by progressive decline in one or more cognitive domains in the brain. Dementia can seriously impair an individual's ability to function independently. Alzheimer's disease, the most common cause of dementia, is an irreversible, progressive brain disorder affecting more than 6.5 million Americans.
The agency's decision was based on two 12-week, randomized, double-blind, placebo-controlled, fixed-dose studies, which determined the effectiveness of Rexulti for the treatment of agitation associated with dementia due to Alzheimer's disease.
The recommended starting dosage for the treatment of such agitation is 0.5 mg taken once daily on days 1 to 7. Patients should increase the dosage on days 8 through 14 to 1 mg once daily, and on day 15 to 2 mg once daily. The recommended target dose is 2 mg once daily, and can be increased to the maximum recommended daily dosage of 3 mg once daily after at least 14 days, based on clinical response and tolerability.
On April 17, an FDA panel, which reviewed REXULTI, voted 9 to 1 that the companies provided sufficient data to allow the identification of a population in whom the benefits of treating agitation associated with Alzheimer's dementia with the drug outweighed its risks.
The FDA granted this application Fast Track designation, a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Rexulti is already approved in the U.S. as an adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment for schizophrenia in adults.
Tiffany Farchione, director of the Division of Psychiatry in the FDA's Center for Drug Evaluation and Research, said, "Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer's disease. 'Agitation' can include symptoms ranging from pacing or restlessness to verbal and physical aggression. These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression."
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