Eisai, a major pharmaceutical company, announced on the 16th that it has applied for national approval for a drug for Alzheimer's disease that it has been developing.
Japanese pharmaceutical company Eisai announced on the 16th that it has submitted an application to the Ministry of Health, Labor and Welfare for approval of the Alzheimer's disease drug lecanemab, which has been jointly developed with Biogen in the United States.
In the brains of patients with Alzheimer's disease, an abnormal protein called "amyloid β" accumulates, and it is believed that this damages nerve cells.
"Lecanemab" is a drug for removing "amyloid β" by binding an artificially made antibody to it.
According to research groups such as "Eisai", the results of the final-stage clinical trial showed that patients who received this drug had about a year and a half of cognitive decline compared to those who received a placebo. It is said that it was suppressed by 27%, and the effect of slowing the progression of symptoms itself was confirmed.
In addition, it has been reported that the drug increases the risk of swelling and bleeding in the brain, but there is no difference in the percentage of people who died during the trial period.
"Lecanemab" was approved in the United States on the 6th of this month under a mechanism called "accelerated approval," which provides faster treatment for patients with serious illnesses.
In Japan, Eisai says, "We want to aim for approval during this year."