Approval Granted to Eisai and Biogen’s Leqembi for Alzheimer’s Treatment in China

China has officially granted approval for the sale of Leqembi, a revolutionary Alzheimer’s treatment jointly crafted by Eisai and Biogen. This regulatory nod positions China as the third nation, after the United States and Japan, to accelerate the availability of this drug aimed at addressing the irreversible and progressive nature of the brain disorder.

The green light from China’s drugs regulator for Leqembi, an antibody designed to impede the advancement of Alzheimer’s in its early stages, underscores its potential impact on patients. The collaborative efforts of Eisai in Japan and Biogen in the United States have paved the way for the drug’s anticipated launch in China, set for as early as the third quarter of 2024. Notably, this swift approval echoes the precedence set by the U.S. Food and Drug Administration, which fast-tracked Leqembi in July 2023, followed by Japan’s health ministry in September of the same year.

While Eisai takes the lead in the distribution of Leqembi in China, the pricing of the drug in the country remains undisclosed. In the United States, the therapy is priced at $26,500 annually, and in Japan, it comes at approximately 2.98 million yen (equivalent to $20,500) per year. However, in May, the U.S. drug cost-effectiveness organization ICER proposed a fair price range of $8,900 to $21,500 annually.

Alzheimer’s disease, characterized by the gradual deterioration of memory and cognitive functions, poses a significant global health challenge. Leqembi’s mechanism involves binding to and reducing soluble and insoluble amyloid-beta deposits in the brains of Alzheimer’s patients, associated with the disease’s progression. It holds the distinction of being the world’s first drug proven to decelerate the advancement of the disease and mitigate related cognitive and functional declines, securing regulatory approval.

China, currently grappling with around 10 million individuals suffering from Alzheimer’s and related dementias, recognizes the significance of Leqembi’s approval. Projections from BioMed Central, a UK-based scientific open-access publisher, estimate that by 2050, this number may surge to 40 million due to the challenges presented by an aging population. With estimates indicating a more than doubling of the Chinese population aged 65 years and above from 172 million to 366 million between 2020 and 2050, addressing Alzheimer’s becomes imperative.

Eisai’s strategy for Leqembi distribution in China involves specialized medical representatives and collaboration with specialists to enhance the diagnostic environment for the disease. The company extends its services by offering early consultations through third-party medical specialists and follow-up treatments via Yin Fa Tong, an online health platform affiliated with the Chinese e-commerce giant JD.com.

The approval of Leqembi in China aligns with global endeavors to combat the escalating challenge of Alzheimer’s and related dementias.

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