Eisai Co. and Biogen Inc.’s experimental Alzheimer’s disease drug lecanemab will receive a priority review by U.S. regulators, giving the companies a second shot at a treatment designed to slow progression of the devastating form of dementia.
The Food and Drug Administration accepted the application under the accelerated approval pathway and is expected to complete the review by Jan. 6, the companies said in a statement. The Japanese drugmaker, which is leading the development effort, applied for accelerated approval in May.
The partners will make their case for lecanemab a little more than one year after their other Alzheimer’s drug, Aduhelm, won accelerated approval in the United States. The medicine, which made it to the market despite contradictory data over whether it was effective and over the objections of an FDA advisory committee, never gained widespread acceptance.