MDLinxJapan’s Otsuka Pharma gets FDA Approval for Alzheimer’s Agitation Drug

The FDA has granted approval for Otsuka Pharmaceutical’s brexpiprazole as the first drug to treat agitation in patients with Alzheimer’s disease. Agitation is a common symptom in Alzheimer’s patients, characterized by extreme aggression, restlessness, and anxiety. Previously, non-pharmacological strategies were used initially, followed by off-label use of antipsychotics and anti-depressants in severe cases. The decision to approve brexpiprazole was based on two late-stage studies demonstrating its effectiveness in calming agitated patients with Alzheimer’s, compared to a placebo. The drug was already approved for the treatment of major depressive disorder and schizophrenia in adults.

This approval addresses an unmet need in the management of agitation in Alzheimer’s patients and provides healthcare professionals with a new pharmacological option. Brexpiprazole has shown significant improvement in calming agitated patients, offering a potential solution to help alleviate symptoms associated with the disease. The drug’s approval was supported by sufficient data and endorsement from an advisory panel, reinforcing its benefits outweigh the associated risks.