The approval was based on two late-stage studies, which revealed significant improvement in calming agitated patients with Alzheimer's when compared to a placebo
The approval was based on two Phase 3, 12-week, randomised, double-blind, placebo-controlled fixed-dose studies. (Credit: valelopardo from Pixabay)
Otsuka Pharmaceutical and Lundbeck have secured the US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) of its REXULTI (brexpiprazole), designed to treat agitation-related dementia due to Alzheimer’s disease.
The clearance makes REXULTI the first and only pharmacological treatment approved in the US for such indication.
According to Otsuka, REXULTI has not been indicated as an as-needed (PRN) treatment for agitation associated with dementia due to Alzheimer’s disease.
The approval was based on two Phase 3, 12-week, randomised, double-blind, placebo-controlled fixed-dose studies.
Otsuka president and representative director Makoto Inoue said: “Today marks a major milestone for patients, caregivers, and families navigating the complexities of agitation associated with dementia due to Alzheimer’s disease.
“Otsuka Pharmaceutical will continue its efforts to engage and provide options for those impacted by this devastating condition.”
Both trials assessed agitation symptoms’ frequency in patients with dementia due to Alzheimer’s disease based on the Cohen-Mansfield Agitation Inventory (CMAI) total score.
Otsuka said that the primary endpoint was a change in agitation symptom frequency (CMAI total score) from baseline at week 12 in both late-stage studies.
Overall, the results demonstrated that brexpiprazole, co-developed by Otsuka and Danish drugmaker Lundbeck, was well-tolerated with a low incidence of discontinuations.
Additionally, it showed a safety profile consistent with the known safety profile of brexpiprazole in other indications.
Lundbeck CEO and president Deborah Dunsire said: “This approval is a testament to our commitment and unwavering support of patients and caregivers to lessen the symptoms of agitation associated with dementia due to Alzheimer’s disease.
“We look forward to offering this first FDA-approved treatment option to address this significant unmet need for patients. We are grateful to the patients and caregivers who participated in these important trials.”
Previously, the health regulator granted priority review for the sNDA to both firms.