Pharmaceutical companies Biogen and Eisai said on Tuesday A drug they are developing for Alzheimer’s disease slowed the rate of cognitive decline in a large late-stage clinical trial.
A strong result could increase the chances of this drug gaining approval and bring new hope to a class of Alzheimer’s drugs that has repeatedly failed or produced mixed results.
The positive data also gives Biogen a second chance after the disastrous rollout of another Alzheimer’s drug, Aduhelm. The drug, which gained regulatory approval last year despite little evidence it can slow cognitive decline, has very limited Medicare coverage and is a commercial failure. It has been proven that
The results appear to be stronger with the newer drug, lecanemab. Cognitive decline in a group of volunteers who received lecanemab was reduced by 27% compared to groups who received placebo in a clinical trial enrolling approximately 1,800 participants with mild cognitive impairment or mild Alzheimer’s disease.
Trials of lecanemab, administered by intravenous infusion, have so far been used to test whether clearing the brain of plaques formed by accumulations of a protein called amyloid can slow the progression of Alzheimer’s disease. It was the biggest one. Aduhelm is designed to work in a similar way.
As with previous anti-amyloid drugs, some patients taking lecanemab experienced brain swelling or cerebral hemorrhage, but the prevalence of these side effects was lower than that of Aduhelm and other experimental drugs. .
Eisai had already applied for accelerated approval, a type of approval granted to Aduhelm. Through this process, the Food and Drug Administration permits a drug if there is equivocal evidence of benefit but it affects the biological pathway of the disease in a way that is reasonably likely to benefit the patient. can. The company said Tuesday night it will first continue its accelerated approval process, with an FDA decision expected in early January, after which it will use the new data to seek full approval. requires more testing by the company to prove the drug works.)
Analysts predict that lecanemab, or an effective Alzheimer’s drug, is most likely to become a multi-billion dollar blockbuster.
“For Biogen, it puts them back in the Alzheimer’s game,” said Brian Sconey, an analyst at investment bank Baird. did.
At a news conference Tuesday evening, Eisai Chairman and Chief Executive Officer Ivan Cheung said the results were “the first determination that we can actually slow down Alzheimer’s disease at this very early symptom stage.” It is a positive large-scale clinical trial.”
He said the drug began showing benefits to patients about six months after they started taking the drug, and the benefits increased until the trial ended 18 months after patients started taking the drug.
The companies plan to release more detailed results in November.
Some experts say the drug’s ability to slow cognitive decline (0.45 on an 18-point scale) is modest at best, and may not be a difference that patients with mild early stages of the disease will notice. I’m here.
Ron Schneider, Ph.D., director of the California Alzheimer’s Disease Center at the University of Southern California, said the effect was “small and many do not consider it a clinically minimally significant difference.” But “others will strongly disagree and say it makes clinical sense,” he added.
Dr. Schneider said the “relatively low” rates of brain swelling and bleeding “suggest that lecanemab is easier to use than Aduhelm.”
He added, “We take the press release at face value, which can often be done by chance without any real data or reports, but based on this one study alone, lecanemab It seems most likely to receive the usual marketing approval.”
At the briefing, Cheung said the company considers the results to be “very clinically meaningful,” but added, “Of course, there are different opinions about the definition of clinical meaning for this stage of the disease. There is,” he added.
Other companies are also developing treatments that could disrupt the market for Alzheimer’s drugs, and before Aduhelm there were no new treatments in 20 years. By then, we will report data from two studies of the drug known as gantenerumab. The FDA will decide whether to grant accelerated approval for Eli Lilly’s Alzheimer’s drug, known as donanemab, by early January, and plans to release the results of a large-scale study of the drug in the middle of next year.
Scorny said the results of the study on lecanemab “set a high bar that other agents will find difficult to beat, even if successful.”