Pull to refresh
Logo
Daily Brief
Following Why Sign Up
Herriot Tabuteau

Herriot Tabuteau

Chief Executive Officer, Axsome Therapeutics

Appears in 1 story

Notable Quotes

'Auvelity offers a meaningful new option for patients, families, and clinicians managing one of the most distressing aspects of Alzheimer's disease.' — statement on approval

'We are very pleased to deliver to clinicians and patients a new, effective, FDA-approved treatment option, with a distinct mechanism of action, for this debilitating and critically underserved condition.' — post-approval statement, April 30, 2026

Stories

FDA approves second-ever treatment for Alzheimer's agitation

New Capabilities

Leading commercial launch of second Auvelity indication

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 just now