The U.S. Food and Drug Administration on Thursday approved Otsuka Pharmaceutical’s brexpiprazole for the treatment of agitation in Alzheimer’s patients, making it the first approved drug for the indication, the company said in a statement.
The decision came after an advisory panel voted 9 to 1 in April that the company had enough data to identify people whose benefits from treatment outweigh the risks.
People with Alzheimer’s disease may show signs of extreme aggression or become restless and anxious because the brain loses the ability to negotiate new stimuli as a result of the disease.
Currently in the United States, such patients are first sedated using non-pharmacological strategies, followed by off-label treatment with antipsychotics and antidepressants in worse scenarios.
The approval of brexpiprazole is based on two late-stage studies that showed significant improvement in sedation in agitated patients with Alzheimer’s disease when compared to placebo. Developed in collaboration with Danish pharmaceutical company Lundbeck, brexpiprazole was previously approved in the United States for the treatment of adults with major depressive disorder and schizophrenia.
