Japan's Otsuka Pharma-Lundbeck Partnered Depression Drug Gets FDA Approval For Alzheimer's Agitation

Otsuka Pharmaceutical Co Ltd OTSKF OTSKY (Otsuka) and H. Lundbeck A/S have received FDA approval for Rexulti (brexpiprazole) for use in the treatment of agitation associated with dementia due to Alzheimer's disease.

This approval makes Rexulti the first and only pharmacological treatment approved in the U.S. for agitation associated with dementia due to Alzheimer's disease. 

 It is reported in approximately half of people with Alzheimer's dementia and is associated with earlier nursing home placement.

Rexulti is not indicated as an as-needed (PRN) treatment for agitation associated with dementia due to Alzheimer's disease.

The submission was based on two Phase 3 studies that evaluated the frequency of agitation symptoms in patients with dementia due to Alzheimer's disease based on the Cohen-Mansfield Agitation Inventory (CMAI) total score. 

Overall, the data showed brexpiprazole as being well-tolerated with a low incidence of discontinuations and a safety profile consistent with the known safety profile of brexpiprazole in other indications.

Brexpiprazole was previously approved in the U.S. to treat adults with major depressive disorder and schizophrenia.

Photo by Gerd Altmann from Pixabay