Lundbeck: FDA acceptance, priority review of sNDA for Alzheimer's symptoms med

 

• The supplemental new drug application (sNDA) for brexpiprazole in the treatment of agitation associated with Alzheimer's dementia has been accepted and filed by the FDA under Priority review
• The FDA target date (PDUFA date) for completion of the review is May 10, 2023
• FDA is currently planning to hold a Psychopharmacologic Drugs Advisory Committee meeting
• If approved, brexpiprazole would be the first pharmacological treatment indicated for agitation in patients with Alzheimer's dementia in the U.S.

https://www.marketscreener.com/quote/stock/LUNDBECK-1412962/news/Lundbeck-announces-FDA-acceptance-and-priority-review-of-sNDA-for-brexpiprazole-for-the-treatment-of-42678197/