Eisai

Eisai files for approval of Alzheimer’s drug in Japan

Jan 16 (Reuters) – Japanese drugmaker Eisai Co Ltd (4523.T) said on Monday it had submitted a marketing authorisation application in Japan for its Alzheimer’s drug lecanemab, which was recently granted accelerated approval in the United States.

The drug, developed in partnership with Biogen Inc (BIIB.O), is an antibody that has been shown to remove sticky deposits of a protein called amyloid beta from the brains of those in the early stages of the mind-wasting disease.

The company’s application is 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 Shivani Tanna in Bengaluru; Editing by Tom Hogue and Gerry Doyle

Our Standards: The Thomson Reuters Trust Principles.

Source: Reuters