But the detailed results also concluded that the drug, lecanemab, was associated with “adverse events” and warranted further study.
Marwan Sabbagh, a neurologist at the Barrow Neurological Institute and co-author of the study, described two patient deaths that raised concerns about the drug’s safety before Tuesday’s presentation. “Causation with lecanemab is a bit difficult,” he said, noting that both patients, a 65-year-old woman and an 87-year-old man, had underlying health conditions. Although the rate of brain bleeding is low, he says, the risk increases with medications to prevent blood clotting.
“It could be a relative risk that needs to be managed,” he said Tuesday night at the Alzheimer’s Disease Clinical Trials Conference.
Eisai confirmed both deaths Tuesday night and denied they were drug-related.
New the details have been the subject of intense anticipation from doctors and Wall Street since Eisai and Biogen announced in September that lecanemab slowed cognitive decline by 27% compared to a placebo.
Lecanemab has established itself as the favorite among a class of drugs that seeks to break down clumps of a protein in the brain called beta-amyloid, which researchers have long suspected plays a role in Alzheimer’s disease. The Food and Drug Administration is expected to make a decision on approving the drug as early as January. This could mean a multi-billion dollar price tag for treating a progressively debilitating disease that affects 6 million Americans and has few approved therapies.
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“This is the best data we’ve seen on Alzheimer’s disease in a pivotal trial,” Myles Minter, biotechnology analyst at William Blair, said of the first results announced in September.
Positive lecanemab results follow controversy over another drug developed by Eisai and Biogen, aducanumab. The drug, known under the brand name Aduhelm, was approved by the FDA last year despite conflicting data on its effectiveness. Aduhelm fizzled commercially after Medicare refused to reimburse him extensively.
Lecanemab is designed work by removing clumps of tiny proteins called amyloids from the brain. Yet despite the drug’s early success, some experts remain skeptical that targeting these amyloids is the key to treating Alzheimer’s disease. This month, Roche announced disappointing results for its anti-amyloid drug.
Matthew Schrag, professor of neurology at Vanderbilt University Medical School, said the lecanemab trial was well designed and showed strong statistical results on a cognitive measure. But he doubted the drug would lead to any noticeable improvement for many patients and noted that the drug could cause significant side effects.
“I fear that any minor benefits will be overshadowed by the practical difficulties of living with the drug and the substantial risks associated with taking the drug,” he said in an interview.
Eisai and Biogen reported that patients in the trial experienced brain swelling and bleeding, which are known to be complications of anti-amyloid drugs, but the companies said the rates were in line with expectations. However, concerns about the drug’s safety have been heightened by the two patient deaths.
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On Sunday, Science magazine reported that a patient taking lecanemab died after suffering a stroke and receiving a drug to remove blood clots. This followed a report last month by Stat news that another patient in the trial had died while taking blood thinners. Both deaths are believed to be due to a condition in which amyloid binds to blood vessels in the brain and makes them more susceptible to rupture.
Research analysts at investment bank UBS questioned whether the deaths would prompt FDA restrictions for patients taking blood thinners, which they say could account for up to 20% of patients with the disease. Alzheimers.
Libby Holman, spokeswoman for Eisai, said the deceased patients had underlying medical conditions and risks, including taking drugs that prevent blood clots, that contributed to their deaths. “It is Eisai’s assessment that the deaths cannot be attributed to lecanemab,” she said, adding that the cerebral hemorrhage death rate was 0.1% for patients in the placebo groups. and treatment.
Despite the unknowns about lecanemab’s risks and benefits, it remains appealing to Alzheimer’s patients eager for any option to slow its degenerative effects and help find a cure.
Hugh Courtney, a 59-year-old economist diagnosed with early-onset Alzheimer’s disease, said he felt lucky to have taken part in the clinical trial although he is unsure of the magnitude of the benefits. he pulled out.
“It’s hard to say how much it’s changed, quite frankly,” he said of the lecanemab infusions he receives about twice a month. Still, he said, “it gave me a purpose, a concrete way to help.”
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