Alzheimer’s Disease Intravenous Infusion Treatment Launches in Japan on December 20th

Eisai Co., Ltd. and Biogen Inc. today announced that humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody LEQEMBI® Intravenous Infusion (200 mg, 500mg, lecanemab) is scheduled to launch in Japan on December 20, 2023.

LEQEMBI received manufacturing and marketing approval for the indication of slowing progression of mild cognitive impairment and mild dementia due to Alzheimer's disease (AD) in Japan on September 25, 2023.

The pending launch in Japan marks the second country to have LEQEMBI on the market, following the U.S. Food and Drug Administration (FDA) approval in July 2023.

In the U.S., treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials, says the FDA.

"The availability of LEQEMBI opens a new era in the treatment of AD, potentially giving patients and their families additional valuable time together and further positions Japan as a leader in caring for an elderly population," said Christopher A. Viehbacher, President and Chief Executive Officer of Biogen, in a press release on December 13, 2023.

"We will work alongside Eisai to engage the medical community and support the patient journey, especially early diagnosis, as mounting evidence suggests early intervention may provide a greater impact on disease progression."