Axsome Therapeutics won FDA approval to expand Auvelity’s label to include Alzheimer’s disease agitation. The approval provides access for patients with a condition affecting up to about three-quarters of people with Alzheimer’s agitation, and it positions Auvelity as the second FDA-approved treatment in this indication. Industry reporting around the decision points to a PDUFA date of April 30 and a wholesale acquisition cost of $1,248 for a 30-day supply, with launch planned for June. Axsome’s approval also highlights label dynamics in the category, including the boxed-warning profile of the earlier approved competitor. The expanded indication broadens Auvelity’s potential market reach in a commercially attractive neurology segment.