Otsuka/Lundbeck’s Rexulti Appears Effective For Alzheimer’s Dementia Agitation, US FDA Says

 
• By Sue Sutter

But agency seeks advisory committee input on the drug’s overall benefit-risk profile for this indication, taking into account the increased risk of death among elderly patients receiving antipsychotics and safety issues with other drugs often used off-label to treat dementia.

Alzheimer's patient
Rexulti could become the first approved treatment for agitation associated with Alzheimer's dementia. • Source: Shutterstock

More from US FDA Performance Tracker

More from Regulatory Trackers