Japan panel OKs Alzheimer's drug, paves way for formal approval

TOKYO, Aug. 21 Kyodo - A Japanese health ministry panel on Monday gave the green light for the manufacture and sales of an Alzheimer's drug developed by Japanese pharmaceutical company Eisai Co. and U.S. firm Biogen Inc., paving the way for its formal approval.

Lecanemab, the drug's generic name, is poised to be the first in Japan to both treat the underlying cause of Alzheimer's disease and slow its symptom progression.

Alzheimer's is the most prevalent form of dementia, and it is projected that by 2025, around 7 million people in Japan will be affected, representing approximately one in five individuals aged 65 and above.

The drug is a special type of antibody that targets a protein called amyloid beta, which is considered the cause of the disease. The plaque-like protein accumulates inside the brain and destroys nerve cells.

The new drug is for early-stage treatment of Alzheimer's and for people with mild cognitive impairment.

The U.S. Food and Drug Administration formally approved the drug, branded Leqembi, on July 6.

The treatment is likely to be expensive when made available in Japan, given Eisai has set its price in the United States at $26,500 per year.

Eisai said clinical trials demonstrated the new drug curbed the progression of symptoms, such as worsening memory and impaired judgment, by 27 percent compared with a placebo.

However, some patients given the drug experienced side effects like brain edema and bleeding, it said.

==Kyodo