Commercialization: Marketing & Distribution
Eisai files for approval of Alzheimer's drug in Europe
Reuters - 10 Jan, 2023
Japanese drugmaker Eisai Co Ltd (4523.T) said on Tuesday it had submitted a marketing application to the European health regulator for review of 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. Nearly all previous experimental drugs using the same approach have failed.
The company's application to the European Medicines Agency is based on results from a late-stage study in which the drug was shown to slow down the rate of cognitive decline in patients with early Alzheimer's by 27%, compared with a placebo.
Eisai also reiterated its plans to apply for marketing authorization of the drug in Japan by the end of its business year on March 31.
Last week, the company 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
Japanese drugmaker Eisai Co Ltd (4523.T) said on Tuesday it had submitted a marketing application to the European health regulator for review of 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. Nearly all previous experimental drugs using the same approach have failed.
The company's application to the European Medicines Agency is based on results from a late-stage study in which the drug was shown to slow down the rate of cognitive decline in patients with early Alzheimer's by 27%, compared with a placebo.
Eisai also reiterated its plans to apply for marketing authorization of the drug in Japan by the end of its business year on March 31.
Last week, the company 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