EU regulator accepts for review Alzheimer's treatment from Eisai-Biogen

[January 27, 2023]  (Reuters) -Japanese drugmaker Eisai Co Ltd and Biogen Inc said on Thursday the European Medicines Agency (EMA) had accepted a marketing authorization application for their Alzheimer's disease drug.

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.

Nearly all previous experimental drugs using the same approach have failed.

The application to the EMA was based on results from a late-stage study that showed the drug slowed down the rate of cognitive decline in patients with early Alzheimer's by 27%, compared with a placebo.

Eisai has also filed for approval of the drug in Japan.

The exterior of EMA, European Medicines Agency is seen in Amsterdam, Netherlands December 18, 2020. REUTERS/Piroschka van de Wouw/

Earlier this month, the company 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 Sriparna Roy in Bengaluru; Editing by Subhranshu Sahu and Sriraj Kalluvila)

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