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.
¡°Following the euphoria and challenges of Aduhelm, we are cautious for the prospects of lecanemab,¡± wrote Evan David Seigerman, an analyst at BMO Capital Markets, in a note to clients, saying the situation seems like deja vu to the summer of 2020 when Aduhelm was in the limelight.
Eisai rose as much as 7.4% in Tokyo trading Wednesday, the largest intra-day gain since June 2021.
Lecanemab is the next in a group 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. Biogen and Eisai walked away from their earlier drug, initially known as aducanumab, after the U.S. Medicare program for the elderly refused to pay for it unless patients were participating in clinical trials.
Eisai is conducting a large study known as Clarity AD to show whether lecanemab can safely and effectively slow cognitive decline. Results are expected this fall ¡ª 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.
The next 12 months are poised to be ¡°mission critical¡± in the development of novel Alzheimer¡¯s disease treatments targeting amyloid, Seigerman wrote. ¡°While we are mildly encouraged FDA¡¯s action, the lecanemab pivotal data expected in the fall is the make or break moment.¡±
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