Reporter Kim Seong-min of Biospectator
Last May, it was approved by the Ministry of Food and Drug Safety for the fourth time in the world. “The first antibody treatment to be officially approved by the FDA” based on its safety and delayed progression of AD and cognitive function decline.
Eisai Korea announced on the 28th that it has launched a new Alzheimer’s disease (AD) treatment, ‘Leqembi (ingredient name: lecanemab)’ in Korea.
Lechembe is a treatment with a new mechanism that removes amyloid beta (Aβ), one of the main causative agents of Alzheimer’s disease. In Korea, in May, it was approved by Food and Drug Administration as a treatment for adult patients with mild cognitive impairment or mild Alzheimer’s disease due to Alzheimer’s disease. Permission was obtained from the Ministry of Safety and Security. It was the fourth approval worldwide.
Among amyloid beta, Rekembi has the characteristic of reducing amyloid beta plaques in the brain by binding to highly toxic soluble amyloid beta aggregates (protofibrils) and insoluble amyloid beta aggregates (fibrils), and removes the causative substances to progress Alzheimer’s disease. The first antibody to receive official approval from the U.S. Food and Drug Administration (FDA) in July 2023 in recognition of its effectiveness and safety in delaying cognitive function decline and cognitive function decline. It’s a cure.
As a result of the Clarity AD study, which is a phase 3 clinical trial of Rechembe, Lechembe reduced CDR-SB (clinical dementia rating sum of boxes) by 0.45 points compared to the placebo group at 18 months, delaying the progression of Alzheimer’s disease by 27% (95% CI) -0.67, -0.23;
It is estimated that there are approximately 900,000 dementia patients aged 65 or older in Korea, and it is reported that 1 in 10 people aged 65 or older suffer from dementia and 1 in 5 suffer from mild cognitive impairment (MCI). Additionally, it is known that 70% of all dementias are caused by Alzheimer’s disease. The average annual management cost per dementia patient is approximately 21.1 million won, and for severe dementia, the average annual management cost is approximately 33.1 million won.
Koh Hong-byeong, CEO of Eisai Korea, said, “Alzheimer’s disease is a disease that places a great burden on patients and their families and causes unmet medical needs. Until now, there was no drug that could treat the fundamental cause of the disease. However, with the advent of Rechembee, Alzheimer’s disease has improved from mild cognitive impairment to mild cognitive impairment.” “We expect that treatment will be able to enter a new era,” he said. “In the future, Eisai Korea will continue to not only provide a stable supply of Rechemi, but also improve accessibility through the patient assistant program.” “I will try my best,” he said.
Meanwhile, on November 1, Eisai completed the application for approval for once-weekly maintenance treatment of the Lechembe autoinjector subcutaneous autoinjector to the U.S. FDA. If the Lechembe auto-injector self-administration injection is approved, patients will be able to administer Lechembe at home, and the injection time is expected to be reduced from 1 hour for the existing intravenous injection to about 15 seconds.
In addition, Lechembe is recommended for non-carriers or heterozygotes of apolipoprotein E (ApoE) ε4 among adult patients with mild cognitive impairment or mild dementia whose amyloid beta pathology has recently been confirmed by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). Approval was recommended as a target treatment.
