Lundbeck, Otsuka's Rexulti wins FDA approval for agitation linked with Alzheimer's
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The U.S. Food and Drug Administration (FDA) approved the expanded use of H. Lundbeck (OTCPK:HLBBF) (OTCPK:HLUBF) and Otsuka's (OTCPK:OTSKY) (OTCPK:OTSKF) medicine Rexulti (brexpiprazole) to treat agitation associated with dementia due to Alzheimer's disease (AD).
Agitation is a common neuropsychiatric symptom in Alzheimer's dementia.

Japanese drugmaker Otsuka said that the approval makes Rexulti the first and only pharmacological treatment approved in the U.S. for this use.
The FDA had previously granted priority review to the company's supplemental New Drug Application (sNDA) for the drug.
The approval was backed by data from two phase 3 studies prescription medicine used:
Rexulti is already approved to treat schizophrenia in adults and children ages 13 years and older; and for use with other antidepressant drugs to treat major depressive disorder in adults.
Alzheimer's drug developers â Biogen (BIIB), Eisai (OTCPK:ESALF) (OTCPK:ESAIY), Eli Lilly (LLY) Prothena (PRTA), Acumen Pharmaceuticals (ABOS), Annovis Bio (ANVS), and Anavex Life Sciences (AVXL).