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Axsome's Auvelity Approved for Alzheimer's Agitation
1 May
Summary
- FDA approves Axsome Therapeutics' Auvelity for Alzheimer's agitation.
- Auvelity offers a safer alternative to antipsychotics for patients.
- The drug is expected to launch for this new indication in June.
The U.S. Food and Drug Administration has granted approval to Axsome Therapeutics' drug, Auvelity, for the treatment of agitation in individuals with Alzheimer's disease. This decision, announced on Thursday, caused Axsome's shares to rise significantly in afternoon trading.
Auvelity presents an alternative to antipsychotic drugs, which are currently the only other FDA-approved treatment for Alzheimer's-related agitation, such as Rexulti. Unlike antipsychotics, Auvelity does not carry the regulator's most severe warning regarding increased mortality risk in elderly dementia patients.
The drug, which was previously approved in 2022 for depression, functions by calming specific neurotransmitters in the brain associated with behavioral symptoms like agitation and aggression. Axsome Therapeutics anticipates launching the Alzheimer's disease agitation indication in June. The company has set a list price of $1,248 for a 30-day supply, consistent across its approved uses.
Agitation is a common symptom in Alzheimer's patients, affecting up to 70% of individuals and contributing to faster cognitive decline and increased caregiver burden. Axsome's application for this new indication was supported by data from four late-stage trials involving over 1,000 participants, demonstrating the drug's efficacy in delaying relapse and reducing symptom worsening compared to a placebo.
