US FDA Approves New Alzheimer's Drug... "Slows Disease Progression"

[Image source=AP Yonhap News]

[Asia Economy Reporter Cho Hyun-ui] The U.S. Food and Drug Administration (FDA) approved a new Alzheimer's disease drug on the 7th (local time) for the first time in 18 years.

According to the Washington Post (WP) and others, the FDA approved the new Alzheimer's drug "Aduhelm," jointly developed by the U.S. pharmaceutical company Biogen and the Japanese pharmaceutical company Eisai.

Aduhelm is the first drug to slow the decline of cognitive functions such as memory and language abilities in Alzheimer's patients. It is known to slow the progression of the disease but does not reverse cognitive decline.

Foreign media evaluated, "The drug approved in 2003 managed symptoms such as anxiety and insomnia," adding, "This is the first time a new drug developed to address the fundamental cause of the disease has been approved."

The cost per dose is set at $4,312 (approximately 4.8 million KRW). Considering it is administered every four weeks, the annual cost is about $56,000 (approximately 62.3 million KRW).

Michael Bonatos, CEO of Biogen, called it a "historic moment" and promised, "We will not raise the price for the next four years."

However, the FDA imposed a requirement for follow-up studies on Aduhelm. This is effectively a "conditional approval." If the drug fails to prove its efficacy in subsequent studies, it may be withdrawn from the market.

Alzheimer's disease is known to gradually attack areas of the brain necessary for memory, reasoning, communication, and basic daily tasks. About 6 million people in the U.S. and approximately 30 million worldwide suffer from it, with the number of patients expected to double by 2050.

This content was produced with the assistance of AI translation services.