REUTERS
January 30, 2023 at 12:10 JST
This Dec. 21, 2022 image provided by Eisai in January 2023, shows vials and packaging for their medication Leqembi. (Eisai via AP)
Japanese drugmaker Eisai Co Ltd and U.S. biotech firm Biogen Inc said in a joint statement that the Japanese Ministry of Health, Labor and Welfare has granted priority review status to their Alzheimer’s disease treatment.
The drug, lecanemab, which was recently granted accelerated approval in the United States, is an antibody that has been shown to remove sticky deposits of a protein called amyloid beta from the brains of patients in the early stages of the mind-wasting disease.
In their Jan. 29 statement, the companies said priority review in Japan is granted to new medicines recognized as having high medical utility for serious diseases. Once the priority status has been granted, the target total review period is shortened, they said.
The pair’s application for priority status was based on results from a late-stage study in which the drug was shown to reduce the rate of cognitive decline in patients with early Alzheimer’s by 27%, compared with a placebo.
Nearly all previous experimental drugs using the same approach have failed.
Earlier this month, Eisai also applied for full approval of the drug with the U.S. Food and Drug Administration (FDA) as a treatment for patients in the earliest stages of the neurodegenerative disease.
Eisai files for approval of Alzheimer’s drug in Japan
January 16, 2023
Shionogi’s anti-COVID-19 tablet wins emergency approval for use
November 23, 2022
FDA approves much-debated Alzheimer’s drug panned by experts
June 8, 2021
Alzheimer’s drugmakers seek accelerated FDA review despite U.S. coverage decision
April 9, 2022Remdesivir may be approved in Japan on May 7, health minister says
May 6, 2020Biogen moves forward with potential Alzheimer’s drug, seeks U.S. approval
July 9, 2020
Visit this page for the latest news on Japan’s battle with the novel coronavirus pandemic.
Cooking experts, chefs and others involved in the field of food introduce their special recipes intertwined with their paths in life.
Here is a collection of first-hand accounts by “hibakusha” atomic bomb survivors.
The Asahi Shimbun aims “to achieve gender equality and empower all women and girls” through its Gender Equality Declaration.
Let’s explore the Japanese capital from the viewpoint of wheelchair users and people with disabilities with Barry Joshua Grisdale.
