By Kamal Choudhury and Mariam Sunny
April 30 (Reuters) – The U.S. Food and Drug Administration has approved Axsome Therapeutics’ drug to treat agitation in patients with Alzheimer’s disease, the company said on Thursday, sending its shares 12% higher in afternoon trading.
The drug, branded Auvelity, offers an alternative to antipsychotic drugs for patients with Alzheimer’s-related agitation, marked by restlessness, aggression and emotional distress.
Otsuka Pharmaceutical and Lundbeck’s antipsychotic drug, Rexulti, is the only other FDA-approved treatment for the condition, and carries the regulator’s most serious warning for increased risk of death in elderly people with dementia-related psychosis.
Auvelity, approved in 2022 for depression, is Axsome’s top-selling product and generated $507.1 million in revenue last year.
It works by calming certain neurotransmitters in the brain that regulate cognitive and behavioral symptoms such as agitation and aggression.
UBS analyst Ashwani Verma previously estimated about $2 billion in additional sales for the new indication.
“We believe it is unlikely that Auvelity will receive the black box warning typically associated with antipsychotics, given that it is neither molecularly an antipsychotic nor indicated for the treatment of psychosis,” Verma said in a note ahead of the decision.
It is priced the same across indications, with a list price of $1,248 for a 30‑day supply, the company told Reuters. Axsome expects to launch the Alzheimer’s disease agitation indication in June.
Alzheimer’s disease, the most common form of dementia, affects about 7 million people in the U.S. Agitation occurs in up to 70% of the patients, contributing to faster cognitive decline, heavier burden on caregivers and higher risk of death.
Axsome’s application was based on data from four late-stage trials with more than 1,000 participants, which showed the drug delayed relapse time and reduced worsening of other symptoms compared with placebo.
(Reporting by Kamal Choudhury, Mariam Sunny and Siddhi Mahatole in Bengaluru; Editing by Leroy Leo and Sahal Muhammed)
