FDA approves supplemental new drug application for Rexulti to treat Alzheimer's agitation

Key takeaways:

• Approval makes Rexulti the lone treatment approved for agitation associated with Alzheimer’s dementia.
• Two FDA committees ruled in April that Rexulti’s benefits outweighed risks.

The FDA has approved a supplemental new drug application for Rexulti for the treatment of agitation associated with dementia due to Alzheimer’s disease.

According to a joint press release from Otsuka and Lundbeck, the approval makes Rexulti (brexpiprazole, Otsuka/Lundbeck) the first and only treatment approved in the United States for this common neuropsychiatric symptom of AD, which is reported in nearly half of those with Alzheimer’s dementia.

“Today marks a major milestone for patients, caregivers and families navigating the complexities of agitation associated with dementia due to Alzheimer’s disease,” Makoto Inoue, Otsuka president and representative director, said in the release. “Otsuka Pharmaceutical will continue its efforts to engage and provide options for those impacted by this devastating condition.”

In April, two FDA committees jointly discussed the sNDA for brexpiprazole and voted 9-1 in support of the petition, ruling there was sufficient evidence proving treatment for agitation associated with Alzheimer’s dementia outweighed the risks.

The sNDA submission was based on two phase 3, randomized, double-blind, placebo-controlled fixed-dose studies, which met the primary endpoint of change from baseline to week 12 in agitation symptom frequency using the Cohen-Mansfield Agitation Inventory.

According to the release, participants achieved a 31% greater reduction from baseline in frequency of agitation symptoms compared with placebo. Data also indicate treatment with brexpiprazole is well-tolerated with few discontinuations.

“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,” Deborah Dunsire, Lundbeck CEO and president, said in the release. “We look forward to offering this first FDA-approved treatment option to address this significant unmet need for patients.”