Eisai’s groundbreaking drug for Alzheimer’s disease, Leqembi, is on the verge of receiving approval from Japanese regulators. This comes after the medicine was fully cleared by the US last month. A panel that advises Japan’s health ministry has recommended the approval of Leqembi, as stated in a government announcement. The ministry typically relies on the expert panel’s review before granting clearance to new medicines and usually follows its recommendations.
If approved, Japan will become the second country to give the green light to Leqembi, the first drug that slows the progression of Alzheimer’s disease. Eisai, in collaboration with Biogen, obtained full approval for the drug in the US last month. While the price of the drug was set at $26,500 (€23,345) per year in the US, the cost in Japan will be regulated by the government later this year.
This approval in Japan would be a significant milestone in the treatment of dementia in the country’s rapidly aging society, where more than six million people are currently living with the disease. Alzheimer’s disease is the most prevalent form of dementia, affecting over 55 million individuals worldwide, and it is projected to nearly double every 20 years, according to Alzheimer’s Disease International.
Eisai is also seeking approval of Leqembi in other markets, including Europe and China. The drug, also known as Lecanemab, is one of the most potent antibodies in a new generation of medications that assist in clearing amyloid, a toxic protein that gradually accumulates in the brains of Alzheimer’s patients. Last autumn, it became the first drug to effectively slow the disease in a large-scale clinical trial. Patients who received Leqembi experienced a 27% slower decline over 18 months compared to those who received a placebo.
The full approval of Leqembi in the US last month, following an expedited clearance process in January, is expected to lead to expanded insurance coverage in the world’s largest pharmaceutical market. The approval also came with testing requirements and strict warnings regarding side effects.
Overall, the approval of Leqembi in Japan would be a significant step forward in the fight against Alzheimer’s disease and could potentially provide hope for millions of people suffering from this debilitating condition.