We first wrote about the unmet need for ADA here Agitation In Alzheimer's Disease - An Unmet Need. Axsome Therapeutics was given approval for the indication of Alzheimer's Disease Agitation (ADA), with drug Auvelity from the FDA. This addresses an unmet need, and the first non-antipsychotic approval for ADA. This is the second approval for Auvelity, as it was granted approval for MDD in 2022. Axsome currently has three in-house drug approvals as follows.
- Auvelity for MDD 8/19/22
- Symbravo for Acute Migraine 1/30/25
- Auvelity for ADA 4/30/26
