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Eisai Co. and Biogen Inc.’s experimental Alzheimer’s disease drug lecanemab will receive a priority review by U.S. regulators, bringing their second medicine aimed at slowing progression of the devastating form of dementia closer to the market. 

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. 

Eisai rose as much as 5.9% in Tokyo trading Wednesday, the largest intra-day gain since May 13. 

Lecanemab is the next in a class of drugs that aim to treat the condition by targeting the amyloid plaque that’s a hallmark of the disease. Under the accelerated approval pathway, drugs can be approved based on their ability to remove amyloid from the brain, while companies are conducting studies to prove they also slow cognitive decline.

Thus far, no medicine has proven effective in changing the trajectory or outcome for patients with Alzheimer’s disease, the most common cause of dementia in the elderly. 

The two partners will make their case for lecanemab a little more than one year after their other Alzheimer’s drug, aducanumab, won accelerated approval in the US. 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. 

The companies walked away from the drug, sold under the brand name Aduhelm, after the U.S. Medicare program for the elderly refused to pay for it unless the patients were participating in clinical trials. 

Eisai is conducting a large study from the final stage of development to show whether lecanemab can safely and effectively slow cognitive decline. 

Results are expected this fall -- while the lecanemab accelerated approval application is still likely under regulatory review. If the trial is successful, Eisai and Biogen will be able to apply for full approval.

 

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