LEQEMBI® for Alzheimer’s Now in USA, China, Japan, South Korea

New Approval – Key Points:

1. Approval in South Korea: The Ministry of Food and Drug Safety (MFDS) in South Korea has granted approval for LEQEMBI® (Lecanemab), a humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody.
2. Target Patients: LEQEMBI is approved for treatment in adult patients with mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD (early AD).
3. Mechanism of Action: LEQEMBI selectively binds to both soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), reducing Aβ plaques in the brain.
4. Significant Milestone: LEQEMBI is the first and only approved treatment shown to reduce disease progression and slow cognitive and functional decline.
5. Global Impact: South Korea becomes the fourth country to grant approval, following the U.S., Japan, and China.
6. Dementia Prevalence: Approximately 900,000 dementia patients were estimated in South Korea in 2021, with one in ten people over 65 suffering from dementia.
7. Costs and Commitment: Annual nursing care and medical costs per dementia patient are estimated at 21.1 million KRW, rising to 33.1 million KRW for severe dementia.
8. Collaboration: Eisai leads LEQEMBI development globally, with both Eisai and Biogen co-commercializing and co-promoting the product.

The Leqembi Breakthrough

Leqembi’s breakthrough treatment offers hope for Alzheimer’s patients and underscores the commitment to early diagnosis and treatment.

LEQEMBI is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism.

How Does Leqembi Work?

LEQEMBI selectively binds to soluble Aβ aggregates (protofibrils), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques in AD, thereby reducing both Aβ protofibrils and Aβ plaques in the brain.

Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition.³ Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.⁴

Where is Leqembi Already Approved?

1. The U.S.A.,
2. Japan,
3. China,
4. South Korea is the fourth country to grant approval,.