Japan gives priority review status to Alzheimer's drug developed by Eisai, Biogen
Japanese drugmaker Eisai Co Ltd and US 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 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 US Food and Drug Administration (FDA) as a treatment for patients in the earliest stages of the neurodegenerative disease. —Reuters