Eisai Co. and Biogen Inc. US’s experimental Alzheimer’s disease drug lecanumab will receive priority review by US regulators, bringing their second drug aimed at slowing the progression of a devastating form of dementia closer to market.
The Food and Drug Administration has accepted applications under the expedited approval route and expects to complete the review by January 6, the companies said in a statement. The Japanese drugmaker, which is leading the development effort, applied for accelerated approval in May.
Christian rose up to 5.9% in Tokyo trading on Wednesday, its biggest 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 is a hallmark of the disease. Under the accelerated approval route, drugs may be approved based on their ability to remove amyloid from the brain, while companies are conducting studies to prove that they also slow cognitive decline.
So far, no drug has been shown to be effective in altering the trajectory or outcome for patients with Alzheimer’s disease, the most common cause of dementia in the elderly.
The two partners will lay their stand for lecanumab a little more than a year after another Alzheimer’s drug, aducanumab, received accelerated approval in the US. The drug did not find widespread acceptance in the market, despite conflicting data on whether or not it was effective and despite objections from the FDA advisory committee.
After the US Medicare program for the elderly refused to pay for it, companies moved away from the drug sold under the brand name EduHelm unless patients were participating in clinical trials.
Eisai is conducting a larger study from the late stages of development to show whether lecanumab can safely and effectively slow cognitive decline.
Results are expected this fall – while the Lekenamab accelerated approval application is likely still under regulatory review. If the test is successful, Christian and Biogen will be able to apply for full approval.