According to the Wise News Financial APP, Eli Lilly and Co (LLY.US) announced on Tuesday that its Alzheimer's disease treatment drug donanemab has been approved by the Ministry of Health in Japan, providing a new treatment option for Japanese patients after the approval of Leqembi by ESAIY.US and Biogen (BIIB.US). Japan is the second major market where donanemab has been approved, having been previously launched in the United States under the brand name Kisunla.

The approval of this drug is based on the efficacy and safety data from the third phase clinical study TRAILBLAZER-ALZ 2, which showed that compared to placebo, Kisunla could slow the progression of memory and cognitive problems by 29%. Kisunla demonstrates significant efficacy in slowing cognitive and functional decline in early symptomatic Alzheimer's disease patients. However, the drug also led to brain swelling in almost a quarter of patients and brain hemorrhage in nearly a third of patients, although most cases were mild.

It is understood that Kisunla (donanemab-azbt) is administered once a month by infusion for the treatment of adults with early symptomatic Alzheimer's disease. Similar to Leqembi, Kisunla aims to clear β-amyloid protein associated with Alzheimer's disease in the brain. In the United States, Kisunla's prescription label carries the FDA's strictest "boxed" safety warning, highlighting similar risks of brain swelling and hemorrhage as Leqembi.

The main difference between Kisunla and Leqembi is that its dose is limited, and once brain scans no longer show amyloid plaques, treatment can be stopped. In August of this year, an expert panel from the Japanese Ministry of Health recommended the approval of Eli Lilly and Co's treatment approach.

Alzheimer's disease is the leading cause of dementia cases globally, accounting for as much as 60% to 70%. With the aging population in Japan intensifying, this number is expected to further increase. Currently, over 4.6 million people in Japan have been diagnosed with dementia, and Eli Lilly and Co predicts that this number may surge to over 5 million by 2030.

Data from the Alzheimer's Association shows that the current number of dementia patients in Japan has exceeded 4.6 million, a trend that aligns with forecasts from the National Institute of Population and Social Security Research in Japan. The institute projects that by 2035, individuals aged 65 and older will make up 32.3% of Japan's total population, undoubtedly impacting the prevalence of dementia significantly.