The FDA approved Axsome Therapeutics’ Auvelity (AXS-05) for Alzheimer’s disease agitation, expanding the indication for a drug that already has a history in major depressive disorder. The label now covers a condition that affects up to about three-quarters of patients with Alzheimer’s, putting Auvelity in competition for a high-value specialty segment. Axsome said the approval came on the April 30 PDUFA date and that Auvelity will launch in June at a wholesale acquisition cost of $1,248 for a 30-day supply. The company’s position includes a label that aims to address concerns associated with competing therapies’ warnings. The approval also matters for payer and formulary dynamics in behavioral-neuro markets, where prior approvals have been shaped by safety labeling and risk management requirements.