Otsuka and Lundbeck Receive the US FDA’s Approval for Rexulti (brexpiprazole) sNDA to Treat Agitation Associated with Dementia Due to Alzheimer’s Disease
Shots:
- The US FDA has approved the sNDA of Rexulti for agitation associated with dementia due to AD. The sNDA was based on 2 P-III 12wk. fixed-dose studies (Study 331-12-283) and (Study 331-14-213) evaluating brexpiprazole vs PBO
- The results from both studies showed a 31% greater reduction from baseline in the frequency of agitation symptoms, was well-tolerated with a low incidence of discontinuations. The safety profile was consistent with the known safety profile of brexpiprazole in other indications
- Brexpiprazole was approved in the US for MDD and schizophrenia in adults & in Health Canada for the same indication while in Japan and EU for the treatment of schizophrenia
Ref: Otsuka | Image: Otsuka
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
