news/BIIB/2023.01.29/Japan gives priority review status to Alzheimer's drug developed by Eisai, Biogen.txt

Jan 29 (Reuters) - Japanese drugmaker Eisai Co Ltd
and U.S. biotech firm Biogen Inc said in a
joint statement that the Japanese Ministry of Health, Labour 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 recognised 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.
(Reporting by Baranjot Kaur in Bengaluru; Editing by Stephen
Coates and Kenneth Maxwell)