FDA panel endorses Rexulti as first drug for Alzheimer's agitation.

An FDA advisory committee has voted 9-1 in favor of Rexulti (brexpiprazole), a drug developed by Otsuka and Lundbeck, for the treatment of agitation associated with Alzheimer's dementia. The drug was first approved in 2015 for schizophrenia and as an adjunctive therapy to antidepressants in adults with major depressive disorder. The safety profile of the antipsychotic was on par with others, and all three placebo-controlled Phase III trials contributed to showing the efficacy in the AAD indication.