Eisai and Biogen Announce LEQEMBI® Approval in China
TOKYO and CAMBRIDGE, Mass. — Eisai Co., Ltd. and Biogen Inc. are excited to share that their humanized anti-soluble aggregated amyloid-beta (A?) monoclonal antibody, LEQEMBI (generic name: lecanemab), has recently received approval for once every four weeks intravenous (IV) maintenance dosing from the National Medical Products Administration (NMPA) in China.
Understanding LEQEMBI's Role in Alzheimer's Treatment
Originally approved for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia, LEQEMBI's new dosing regimen provides an exciting step in therapy management. Following an 18-month initiation phase of 10 mg/kg administered every two weeks, healthcare providers can now transition patients to a maintenance schedule of 10 mg/kg every four weeks, optimizing treatment efficacy.
The Nature of Alzheimer's Disease
Alzheimer's disease is a complex and relentless condition leading to cognitive decline. Characterized by the accumulation of amyloid-beta plaques and neurofibrillary tangles composed of tau protein, it initiates a neurotoxic process well before the onset of noticeable symptoms. Research suggests that A? protofibrils and tau tangles significantly contribute to neurodegeneration, making LEQEMBI an important option as it targets both types, providing a comprehensive therapeutic approach.
Implications for Patients in China
Eisai projects that there were about 17 million patients with MCI or mild dementia due to Alzheimer's in China, a number likely to rise as the population ages. The launch of LEQEMBI's IV maintenance dosing adds a significant tool to healthcare providers caring for this growing cohort, furthering Eisai’s commitment to improving Alzheimer’s care.
Collaboration between Eisai and Biogen
Eisai has led the global efforts in lecanemab's development while Biogen co-commercializes and promotes the product. This collaboration is vital in both regulatory submission processes and distribution efforts, particularly within Chinese markets where Eisai manages product distribution through specialized Medical Representatives.
Media Contacts
Eisai Co., Ltd.
Public Relations Department
+81 (0)3-3817-5120
Eisai Europe, Ltd.
EMEA Communications Department
+44 (0) 7739 600678
EMEA-comms@eisai.net
Eisai Inc. (U.S.)
Libby Holman
+1-201-753-1945
Libby_Holman@eisai.com
Biogen Inc.
Madeleine Shin
+1-781-464-3260
public.affairs@biogen.com
Frequently Asked Questions
What is LEQEMBI?
LEQEMBI, also known as lecanemab, is a monoclonal antibody approved for treating Alzheimer's disease, specifically targeting amyloid-beta aggregates.
How does LEQEMBI work?
LEQEMBI addresses Alzheimer's pathology by targeting both amyloid plaques and protofibrils to help mitigate neurodegeneration.
Who can benefit from LEQEMBI?
Patients with mild cognitive impairment or mild dementia due to Alzheimer's disease can benefit from LEQEMBI's treatment regimen.
Is LEQEMBI available for all Alzheimer’s patients?
Currently, LEQEMBI is approved for patients in early stages of Alzheimer’s. Ongoing evaluations may expand its availability.
What is the future of LEQEMBI?
LEQEMBI’s global approvals and ongoing clinical trials suggest strong potential for its use in various stages of Alzheimer’s treatment, enhancing patient outcomes worldwide.
