Japan Approves Alzheimer’s Disease Therapy

BioArctic AB and Eisai announced today that LEQEMBI® Intravenous Infusion had been approved in Japan as a treatment for slowing the progression of mild cognitive impairment and mild dementia due to Alzheimer's disease (AD).

LEQEMBI is a humanized immunoglobulin gamma 1 monoclonal antibody (mAbs) directed against aggregated soluble and insoluble forms of Aβ.

LEQEMBI is the first and only approved treatment shown to reduce the rate of disease progression and slow cognitive and functional decline by selectively binding to and eliminating the most toxic Aβ aggregates that contribute to neurotoxicity in AD.

Japan is the second country to approve LEQEMBI, following the Food and Drug Administration (FDA) approval in the U.S. in July 2023.

"The approval of LEQEMBI in Japan is another important step in the fight against Alzheimer's disease," said Gunilla Osswald, CEO of BioArctic, in a press release on September 25, 2023.

Eisai serves as the lead of LEQEMBI development and regulatory submissions globally, with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

BioArctic has the right to commercialize lecanemab in the Nordic region, and currently, Eisai and BioArctic are preparing for joint commercialization in the region.

According to the Alzheimer's Association, AD is a degenerative brain disease caused by complex brain changes following cell damage, leading to dementia.

As of September 2023, The U.S. FDA, the European Medicines Agency, and the United Kingdom's NHS have not authorized preventive AD vaccines.