FDA approves drug shown to slow down Alzheimer's disease

The U.S. Food and Drug Administration has fully approved the first drug shown to slow down Alzheimer's disease, jointly developed by U.S. and Japanese pharmaceutical companies. The drug could slow down the disease's progression for people in the early stages, making it a milestone in overcoming Alzheimer's disease.

In January, the drug called Leqembi received accelerated approval from the FDA. The full approval of the drug on Thursday reflects the FDA's assessment that Leqembi has proven its clinical effectiveness. Eisai, a Japanese pharmaceutical company, and U.S. Biogen developed it. The drug can remove beta-amyloid from the brain, which has been identified as the cause of Alzheimer's.

In studies reviewed by the FDA, the treatment slowed cognitive decline from early Alzheimer's disease by 27%, equivalent to five months, over an 18-month clinical trial period where participants received the treatment every two weeks. On the 18-point cognitive scale, which assesses cognitive functions like memory and problem-solving, patients treated with Leqembi showed a 0.5-point lower decline in scores compared to the placebo group.

“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in the announcement. “This study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”


Hyoun-Soo Kim kimhs@donga.com