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 — Biogen (BIIB), Eisai (OTCPK:ESALF) (OTCPK:ESAIY), Eli Lilly (LLY) Prothena (PRTA), Acumen Pharmaceuticals (ABOS), Annovis Bio (ANVS), and Anavex Life Sciences (AVXL).