Japan's Otsuka Pharma gets US FDA approval for Alzheimer's agitation drug | Inquirer News

Japan’s Otsuka Pharma gets US FDA approval for Alzheimer’s agitation drug

/ 11:58 AM May 11, 2023

US FDA

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

The U.S. Food and Drug Administration approved Otsuka Pharmaceutical’s brexpiprazole to treat agitation in patients with Alzheimer’s on Thursday, making it the first approved drug for the indication, the company said in a statement.

The decision comes after an advisory panel in April voted 9-1 that the company had enough data to identify the population in whom benefits from the treatment outweigh its risks.

Article continues after this advertisement

Patients with Alzheimer’s sometimes show signs of extreme aggression or become restless and anxious as their brain loses its ability to negotiate with new stimulus as a result of the disease. Presently in the U.S., such patients are calmed down using non-pharmacological strategies first, only to be followed by off-label treatment with antipsychotics and anti-depressants in worse scenarios. The approval of brexpiprazole is based on two late-stage studies, which showed significant improvement in calming agitated patients with Alzheimer’s, when compared with a placebo. Brexpiprazole, co-developed with Danish drugmaker Lundbeck, was previously approved in the U.S. to treat adults with major depressive disorder and schizophrenia.

RELATED STORIES

US approves new drug to treat Alzheimer’s disease

Dementia amid COVID: Patients, carers both need care and support

Your subscription could not be saved. Please try again.
Your subscription has been successful.

Subscribe to our daily newsletter

By providing an email address. I agree to the Terms of Use and acknowledge that I have read the Privacy Policy.

TAGS: Alzheimer’s, Drugs, US FDA

Your subscription could not be saved. Please try again.
Your subscription has been successful.

Subscribe to our newsletter!

By providing an email address. I agree to the Terms of Use and acknowledge that I have read the Privacy Policy.

© Copyright 1997-2024 INQUIRER.net | All Rights Reserved

This is an information message

We use cookies to enhance your experience. By continuing, you agree to our use of cookies. Learn more here.