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Eisai Says Alzheimer’s Drug Will Get Priority Review in US

  • Regulators to rule on the application by early January
  • Key study results are due this fall as the review is underway
Updated on

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.