Pharmaceutical companies Biogen and Eisai say on Tuesday that a drug they are developing for Alzheimer’s disease slowed cognitive decline in a large late-stage clinical trial.
The strong results increase the drug’s chances of approval and offer new hope for a class of Alzheimer’s drugs that have repeatedly failed or produced mixed results.
The positive data also gives Biogen a second chance after the company launched another disastrous Alzheimer’s drug, Aduhelm. That drug won regulatory approval last year although there is little evidence it can slow cognitive decline, receiving only Strong limited coverage by Medicare and proved to be a commercial failure.
Results appear to be stronger for the new drug, lecanemab. Cognitive decline in volunteers taking lecanemab was reduced by 27% compared to placebo in the clinical trial, which involved nearly 1,800 participants with mild cognitive impairment or Alzheimer’s disease, the companies say. mild, the companies said.
The trial of lecanemab, given through an intravenous line, is the largest trial to date to test whether the removal of plaques in the brain that are formed by the buildup of a protein called amyloid Can 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 brain swelling or bleeding in the brain, but the incidence of these side effects was lower than with Aduhelm and other experimental drugs.
Eisai applied for expedited approval, the type of approval granted to Aduhelm. This process allows the Food and Drug Administration to give drugs the green light if they have uncertain evidence of benefit but affect the biological pathway of the disease in a way that is deemed beneficial for the patient. patient reasonably. The company said Tuesday night that it will first continue the expedited approval process, with an FDA decision expected in early January, and then use newer data to seek approval. full agreement. (Rapid approval requires companies to conduct further tests and prove that their drugs work.)
Analysts predict that lecanemab, or any effective Alzheimer’s drug, will most likely be a billion-dollar blockbuster.
“For Biogen, it puts them back in the Alzheimer’s game,” said Brian Skyers, an analyst at investment bank Baird. Biogen’s share price spiked on Wednesday, up 43% in early trading.
During a press conference with reporters on Tuesday night, Ivan Cheung, Eisai’s president and chief executive officer, said the results represent “the first major clinical trial to be positive that shows you really can could slow Alzheimer’s at this very early symptomatic stage.”
He said the drug started to benefit patients about six months after they started taking it, and that benefit increased until the trial ended, 18 months after patients started taking it. medicine.
The companies plan to present 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 the difference patients in mild early stages make. of the disease will be noticed.
Dr Lon Schneider, director of the California Alzheimer’s Disease Center at the University of Southern California, said the impact was “very small and would not be considered by many to be a clinically important difference”. However, he added, “others would completely disagree and say it makes clinical sense.”
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 issuing a press release at face value is often a good thing to do without actual data or reporting, it seems likely that lecanemab will get approval.” Marketing deals are often based solely on this one study.”
During the press conference, Mr. Cheung said the company considers the results “clinically significant,” but he added, “Of course, there are different opinions on determining clinical significance.” ready for this stage of the disease.”
Other companies are also developing treatments that could shake up the Alzheimer’s drug market, something Aduhelm hasn’t seen a new treatment for in two decades. Before the end of the year, Roche is expected to report data from two studies of a drug called gantenerumab. The FDA is expected to make a decision on whether to expedite approval of Eli Lilly’s Alzheimer’s drug called donanemab in early January, with results from a larger study of the drug. That will take place in the middle of next year.
The results from the lecanemab study “set a high standard that I think will be difficult for other drugs, if they are successful, to be able to beat,” Mr. Skyers said.
