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In early 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to a new Alzheimer’s drug called Leqembi. (Biogen, a biotechnology company, and Eisai, a pharmaceutical ...
The drug was approved in January under the FDA’s Accelerated Approval pathway, which allows the organization to approve drugs for serious conditions where there is an unmet medical need, based ...
“This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease," said FDA's neurology drug director, Dr. Teresa Buracchio, in a statement.
This Dec. 21, 2022 image provided by Eisai in January 2023, shows vials and packaging for their medication Leqembi. On Friday, Jan. 6, 2023, U.S. health officials approved Leqembi, a new Alzheimer ...
After a lull of nearly 2 decades, the Food and Drug Administration (FDA) has approved some novel drugs for the treatment of Alzheimer’s disease since 2021.
The U.S. Food and Drug Administration on Thursday granted standard approval to Eisai and Biogen's Leqembi for patients with Alzheimer's disease. The FDA decision is expected to trigger broader ...
The agency’s approval was based on a late-stage clinical trial of 1,700 people that showed the drug slowed the progression of Alzheimer’s by about 35% after 18 months, compared to a placebo ...
The Food and Drug Administration has approved lecanemab, a drug developed by Eisai and Biogen with the goal of slowing the progression of Alzheimer’s disease. FDA grants full approval to new ...