A new drug called Lecanemab could be the first ever to slow the progression of Alzheimer’s after a successful clinical trial.
Lecanemab slowed the rate of cognitive decline in people with early-stage Alzheimer’s by 27% in a large-scale trial, Biogen Inc. and Eisai Co. announced Tuesday. The medicine does not completely stop mental decline or restore cognitive function, but it would be the first to reach the market that significantly slows the progression of the disease, and severe side effects were rare.
An experimental Alzheimer’s drug called lecanemab significantly slowed cognitive decline in a definitive, large-scale trial, the first medicine to clearly blunt its progression https://t.co/NuG81SIoM4 pic.twitter.com/NqZ4vP2V62
— Bloomberg Quicktake (@Quicktake) September 28, 2022
The 27% decline occurred over a period of 18 months, measured by comparing a total of 1,795 patients in a placebo and treated group. Side effects included brain bleeding and swelling, but severe cases were rare, the companies said. Only 2.8% of subjects experienced symptomatic brain swelling.
The breakthrough trial marks a rare but major victory in the fight against the disease first identified in 1901. “These are the most encouraging results in clinical trials treating the underlying causes of Alzheimer’s to date,” the Alzheimer’s Association said in a statement Tuesday reacting to the news.
While the long-term prospects of the treatment aren’t yet clear, there’s hope the benefits will be sustainable and may even increase over time. “There is an important cautionary note however: the magnitude of the delay – which was a slowing of decline – was small,” Mayo Clinic clinical neurologist David Knopman told Bloomberg. “We can only hope that the benefit is durable and could grow with time.”
Biogen and Eisai will apply for full approval from health regulators by the end of March, the companies said, but Lecanemab is already on an “accelerated approval” pathway and is under review by the Food and Drug Administration (FDA).
Lecanemab is the first successful drug developed based on the “amyloid hypothesis,” which argues that a buildup of the protein amyloid over time causes Alzheimer’s disease. Previous drugs aimed at removing amyloid were either failures or produced mixed results. (RELATED: Alzheimer’s Drug Manufacturer Under Federal Investigation For Allegedly Falsifying Research: REPORT)
One such drug was Aduhelm, also developed by Biogen and Eisai. Aduhelm was approved by regulators last year, but Medicare opted not to cover the drug due to mixed trial results, including one major trial which showed no effect on the progression of the disease. At a price of $56,000 per year with no Medicare coverage, the drug was a commercial flop.
An estimated 5.8 million Americans are living with Alzheimer’s, making it the country’s most common form of dementia, according to the Alzheimer’s association.