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Alzheimer’s drug slows cognitive decline in key study

Pharmaceuticals Biogen and Eisai said Tuesday that a drug they are developing for Alzheimer’s disease had slowed the rate of cognitive decline in a large late-stage clinical trial.

The strong results increase the drug’s chances of gaining approval and offer renewed hope for a class of Alzheimer’s drugs that have repeatedly failed or produced mixed results.

The positive data also offers Biogen a second chance after the company’s disastrous launch of another Alzheimer’s drug, Aduhelm. That drug won regulatory approval last year despite little evidence that it could slow cognitive decline, received very limited coverage by Medicare and has proven to be a commercial failure.

The results appear stronger for the new drug, lecanemab. Cognitive decline in the group of volunteers who received lecanemab was reduced by 27 percent compared to the group who received a placebo in the clinical trial, which enrolled nearly 1,800 participants with mild cognitive impairment or mild Alzheimer’s disease, the researchers said. companies.

The trial of lecanemab, which is administered by intravenous infusion, was the largest to date to test whether clearing the brain of plaques formed by the buildup of a protein called amyloid could slow the progression of Alzheimer’s disease. Aduhelm is designed to work in a similar way.

As with previous anti-amyloid drugs, some patients taking lecanemab experienced swelling or bleeding in the brain, but the prevalence of these side effects was lower than with Aduhelm and other experimental drugs.

Eisai had already applied for expedited approval, the type of approval granted to Aduhelm. The process allows the Food and Drug Administration to green light drugs if they have uncertain evidence of benefit but affect the biological pathway of a disease in a way that is considered reasonably likely to benefit patients. The company said late Tuesday that it would first proceed with the expedited approval process, with an FDA decision expected in early January, and then use the newest data to seek full approval. (Accelerated approval requires companies to do more trials and show that their drug works.)

Analysts predict that lecanemab, or any effective Alzheimer’s drug, is likely to be a multimillion-dollar blockbuster.

“For Biogen, it puts them back in the Alzheimer’s game,” said Brian Skorney, an analyst at investment bank Baird.

At a briefing for reporters Tuesday night, Ivan Cheung, Eisai’s chairman and CEO, said the results represent “the first definitively positive large clinical trial to show that you can actually slow down Alzheimer’s disease in this very early symptomatic stage.

He said the drug started to show a benefit for patients about six months after they started taking it, and that the benefit increased until the trial ended, 18 months after patients started taking it.

The companies plan to present more detailed results in November.

Some experts said the drug’s ability to slow cognitive decline (by 0.45 on an 18-point scale) was modest at best and might not be a difference that patients in the early, mild stages of Alzheimer’s would notice. illness.

dr Lon Schneider, director of the California Alzheimer’s Disease Center at the University of Southern California, said the effect “is small and many would not consider it a minimally important difference clinically.” However, he added, “others would strongly disagree and say it’s clinically significant.”

dr Schneider said the “relatively low” rates of brain swelling and bleeding “suggest that lecanemab is easier to use” than Aduhelm.

He added that “while taking a press release at face value, which is often a risky thing to do without having actual data or reports, it appears that lecanemab will most likely receive regular marketing approval based on this study alone.”

At the briefing, Mr. Cheung said the company found the results “highly clinically significant,” but added: “Of course, there are differing opinions on the definition of clinical significance for this stage of the illness”.

Other companies are also developing treatments that could shake up the market for Alzheimer’s drugs, which before Aduhelm had not seen a novel treatment for two decades. Roche is expected to present data from two studies of a drug known as gantenerumab before the end of this year. The FDA is expected to make a decision on whether to grant accelerated approval to an Eli Lilly Alzheimer’s drug known as donanemab in early January, with the results of a larger study of that drug due in the middle of next year.

The results of the lecanemab study “set a high bar that I think will be difficult for the other drugs to exceed if they are successful,” Skorney said.

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