Tag: LEQEMBI

Eisai: “LEQEMBI” (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in China

Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (generic name: lecanemab-irmb) has been approved in China as a treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia. Preparations for launch within the second quarter of Eisai’s FY 2024 (July 1 – September 30, 2024) are underway. LEQEMBI selectively binds to soluble Aβ aggregates (protofibrils*), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques, thereby reducing both Aβ protofibrils and Aβ plaques in the brain. LEQEMBI is ... Read more

Japan – “LEQEMBI Intravenous Infusion”Lecanemab) for the Treatment of Alzheimer’s Disease to be Launched in Japan on December 20

Eisai Co., Ltd. and Biogen Inc. announced today that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI Intravenous Infusion” (200 mg, 500mg, lecanemab) will be launched in Japan on December 20, following its scheduled inclusion in the price listing on the Japan National Health Insurance (NHI) Drug Price List. LEQEMBI received manufacturing and marketing approval for the indication of slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD) in Japan on September 25, 2023. In addition to inclusion in Japan’s NHI Drug Price List, the product’s Optimal Clinical Use Guidelines were agreed at ... Read more

LEQEMBI Wins Best New Drug And Clinical Advance of The Year at The Scrip Awards 2023

Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that Alzheimer’s disease (AD) treatment LEQEMBI® (lecanemab-irmb) was awarded both the Best New Drug and Clinical Advance of the Year for the Phase III Clarity AD study at the Scrip Awards 2023, held by Citeline. The Scrip Awards, now in its 19th year, celebrates the best innovations and achievements of the international biopharma industry. The award for Best New Drug recognizes excellence in pharmaceutical development and celebrates LEQEMBI as the first and only treatment approved in Japan and the United States shown to reduce the rate of disease progression and ... Read more

Japan – LEQEMBI (lecanemab-Irmb) Named One of Time’s Best Inventions of 2023

Eisai Co. Ltd. announced today that TIME has selected Alzheimer’s disease (AD) treatment LEQEMBI® (lecanemab-irmb) as one of THE BEST INVENTIONS of 2023 in the Medical Care category. TIME’s annual list of THE BEST INVENTIONS features “200 extraordinary innovations changing lives.” To compile the list, TIME solicited nominations from its editors and correspondents around the world, and through an open online application process, paying special attention to growing fields, such as AI, green energy, and sustainability. TIME then evaluated each contender on a number of key factors, including originality, efficacy, ambition, and impact. (For more information, please visit http://www.time.com/best-inventions-2023) LEQEMBI ... Read more

Japan – “LEQEMBI Intravenous Infusion” (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in Japan

Eisai Co., Ltd. and Biogen Inc. announced today that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI® Intravenous Infusion” (200 mg, 500mg, lecanemab) has been approved in Japan as a treatment for slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril*) and insoluble forms of Aβ. LEQEMBI is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline by selectively binding to and eliminating the most toxic ... Read more