(Reuters) – Biogen Inc (NASDAQ:) and partner Eisai Co (OTC:) Ltd said on Friday the U.S. Food and Drug Administration has extended the review period for their experimental Alzheimer’s disease treatment by three months.
Biogen’s shares rose 8% premarket.
The FDA will now decide on the marketing application for the drug, aducanumab, by June 7. An FDA panel in November had voted against approval of the drug.
Biogen submitted the aducanumab marketing application to the FDA in July 2020.
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