FDA adcomm votes in favor of first drug for agitation associated with Alzheimer's dementia
A joint meeting of two FDA adcomms on Friday voted 9-1 in favor of Otsuka and Lundbeck’s drug Rexulti (brexpiprazole) for agitation associated with Alzheimer’s dementia (AAD).
First approved in 2015 for schizophrenia and as an an adjunctive therapy to antidepressants in adults with major depressive disorder, Otsuka said at the meeting that all three placebo-controlled Phase III trials contributed to showing the efficacy in the AAD indication, and the safety profile of the antipsychotic was on par with others.
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