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Commercial launch underway; 600-rep salesforce and OnMySide patient support program activated on day of approval
Until May 2023, no drug was approved in the United States to treat the agitation that affects up to three-quarters of people with Alzheimer's disease. Doctors reached for antipsychotics off-label, a class of medicines that carries a black-box warning for increased death risk in older dementia patients. On April 30, 2026, the Food and Drug Administration (FDA) approved Axsome Therapeutics' Auvelity for the indication, doubling the menu of approved options from one to two. In its own press announcement, the FDA described the action as approving the 'first non-antipsychotic drug to treat agitation associated with dementia' — a framing that underscores what distinguishes Auvelity from the incumbent treatment, Rexulti.
Updated May 1
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