ESALF - Lundbeck Otsuka's Rexulti wins FDA approval for agitation linked with Alzheimer's

2023-05-11 05:56:21 ET

• 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 ).

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