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PRINCETON, N.J. & DEERFIELD, Ill.--(BUSINESS WIRE)--Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Lundbeck LLC (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of REXULTI® (brexpiprazole) for use in the treatment of agitation associated with dementia due to Alzheimer’s disease.
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).
Seeking a new approval to curb agitation in Alzheimer's patients, Lundbeck and Otsuka Pharmaceutical are gearing up for an important test Friday. And it appears the FDA is open to a potential nod for their atypical antipsychotic Rexulti.
A label expansion is likely in the cards for Otsuka and Lundbeck’s drug Rexulti (brexpiprazole) as the FDA said ahead of a Friday adcomm that the duo provided enough efficacy evidence for Rexulti to be approved as a treatment for agitation associated with Alzheimer’s dementia (AAD).