Japanese pharmaceutical company Donanemab, partner of Eli Lilly (LLY.US), secures another victory: approval in Japan accelerates the expansion of the global market for Alzheimer's disease treatment.

Eli Lilly and Company (LLY.US) announced on Tuesday that its Alzheimer's disease treatment drug donanemab has been approved by the Japanese Ministry of Health, providing a new treatment option for patients in Japan after Eisai (ESAIY.US) and Biogen's (BIIB.US) Leqembi. Japan is the second major market where donanemab has been approved, following its launch in the United States under the brand name Kisunla. The approval of the drug is based on the efficacy and safety data from the phase 3 clinical trial TRAILBLAZER-ALZ 2, which showed that Kisunla can slow the progression of memory and cognitive problems by 29% compared to placebo. Kisunla demonstrated significant efficacy in slowing cognitive and functional decline in early symptomatic Alzheimer's disease patients. However, the drug also resulted in brain swelling in nearly a quarter of patients and brain hemorrhage in almost a third of patients, although most cases were mild. It is reported that Kisunla (donanemab-azbt) is administered once monthly for treatment in adults with early symptomatic Alzheimer's disease. Like Leqembi, Kisunla aims to clear -amyloid plaques in the brain associated with Alzheimer's disease. In the United States, Kisunla's prescription label includes the FDA's most stringent "boxed" safety warning, highlighting similar risks of brain swelling and bleeding as Leqembi. However, the main difference between Kisunla and Leqembi is that its dosage is limited, and treatment can be stopped once brain scans no longer show amyloid plaques. In August of this year, an expert panel from the Japanese Ministry of Health recommended the approval of Eli Lilly's treatment approach. Alzheimer's disease is the leading cause of dementia cases worldwide, accounting for 60% to 70% of cases. With the aging population in Japan, this number is expected to rise further. Currently, there are over 4.6 million people diagnosed with dementia in Japan, and Eli Lilly predicts that this number may increase 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 the predictions of the National Institute of Population and Social Security Research in Japan. The institute forecasts that by 2035, individuals aged 65 and older will make up 32.3% of the total population in Japan, which will undoubtedly have a significant impact on the prevalence of dementia.