(Reuters) – Biogen Inc said on Wednesday that it submitted a marketing application for its experimental Alzheimer’s disease therapy, aducanumab, to the U.S. Food and Drug Administration (FDA), sending its shares up more than 8% in premarket trading.
Currently, there are no drugs approved by the FDA that can reverse the mental decline resulting from Alzheimer’s disease, and investors believe that a successful treatment for the memory-robbing disease could bring in billions of dollars in sales.
The U.S. FDA now has 60 days to decide whether to accept the application for review, Biogen and partner Eisai Co Ltd said in a joint statement.
Biogen and Eisai decided in March 2019 to end two late-stage trials of aducanumab based on a so-called “futility analysis” of data, which revealed the trials had little hope of succeeding.
The companies reversed course in October, reviving plans to seek U.S. approval for aducanumab, saying detailed analysis of discontinued trials showed the drug to be effective when administered in high quantities to patients over an extended period.
(Reporting by Manas Mishra in Bengaluru; Editing by Anil D’Silva)
