Alzheimer's drug Leqembi./Eisai

The new drug Leqembi, which delays Alzheimer’s disease, is expected to be introduced in South Korea soon. In Japan, where Leqembi was introduced earlier, about 7,000 people are expected to receive the medication this year. The number of patients taking Leqembi in the United States is also rapidly increasing.

According to industry sources, the Ministry of Food and Drug Safety of the Republic of Korea recently completed a review of the safety and efficacy of Leqembi, and approval could be granted as early as this month. Leqembi is a new Alzheimer’s treatment drug jointly developed by the American pharmaceutical company Biogen and the Japanese pharmaceutical company Eisai.

Alzheimer’s disease is a condition where abnormal amyloid-beta proteins accumulate in the brain, leading to cognitive decline and memory loss. It mainly affects people over age 65 and is also known as senile dementia. Leqembi works by preventing the buildup of amyloid-beta proteins in the brain, thereby slowing the progression of dementia. It was approved by the U.S. Food and Drug Administration in July last year and by Japan’s Ministry of Health, Labour and Welfare in September of the same year.

However, even if Leqembi receives approval from the Korean Ministry of Food and Drug Safety, it may take some time for many patients to be prescribed and start the medication due to its high cost. In the U.S., the annual cost of Leqembi is around 35 million won, and in Japan, it is about 27 million won. Eisai Korea is reportedly preparing for price negotiations with the National Health Insurance Service.

Industry experts suggest that, based on the example of Japan, usage in South Korea could increase quickly despite the high cost once approval is granted. In Japan, Leqembi was included in the public health insurance system last December. According to Eisai, about 100 people received prescriptions within the first two months after insurance coverage started, and about 300 by March. As of the end of March, around 350 hospitals in Japan had introduced Leqembi, and 3,500 specialists had been trained on its administration and side effects.

Eisai stated, “The number of patients is increasing faster than expected,” and predicted that 7,000 patients would be treated in Japan by the end of this year.

Leqembi has been on sale in the U.S. since the second half of last year. However, market response in the U.S. has been less enthusiastic compared to Japan. Biogen reported in its first-quarter earnings release that “Leqembi’s performance was below expectations.” According to Biogen, fewer than 5,000 patients were receiving Leqembi as of the end of March, half of the target of 10,000 patients set by Biogen and Eisai.

Reuters analyzed that the slower uptake in the U.S. is due to the healthcare system. Unlike Japan, the U.S. has fewer local hospitals, making it difficult for patients to visit, and the cost of treatment itself can be burdensome.

Biogen acknowledged that while the initial performance of Leqembi fell short of expectations, the growth trend is clear. Biogen CEO Chris Viehbacher stated in the earnings call, “The momentum of Leqembi is steadily increasing, with a rise in the number of new patients each month.” Biogen’s first-quarter U.S. sales of Leqembi were $19 million, exceeding the expected $11 million.