FDA Approves Lecanemab, a New Alzheimer’s Drug

On Jan. 6, the U.S. Food and Drug Administration (FDA) authorized a new drug to deal with Alzheimer’s illness in its early phases.

Lecanemab, which will likely be out there below the identify Leqembi, can sluggish the cognitive decline related to Alzheimer’s illness by 27%, in accordance with information submitted to the FDA by the drug’s builders, Eisai and Biogen. It’s solely the second medicine to indicate any enchancment in neurodegeneration, a key criterion within the FDA’s consideration for approval.

“For a long time, this is what we have been looking for,” says Dr. Sam Gandy, professor of neurology and psychiatry and director of the Mount Sinai Center for Cognitive Health (who was not concerned in making or testing the drug). “We’d certainly like to see a larger benefit, but this is a step in the right direction.”

What is lecanemab?

Lecanemab is the most recent in a lengthy line of medication that targets amyloid, a protein that builds up abnormally within the brains of individuals with Alzheimer’s. It works on a type of amyloid referred to as protofibrils which can be notably poisonous to mind neurons. The drug attaches to those items of amyloid, stopping them from clustering collectively to kind the plaques that may compromise nerve operate.

While the 27% enchancment in cognitive check scores among the many sufferers taking lecanemab in comparison with these receiving placebo over 18 months could not appear dramatic, it may sluggish decline sufficient to provide sufferers months and even years of extra time with fewer reminiscence issues.

That’s essential for individuals like Jerry Fair, who was recognized with Alzheimer’s in 2019 and took part within the trial of lecanemab on the Cleveland Clinic. “It’s not a cure-all,” he says. “But if we can slow [Alzheimer’s] down a little—if it gives us a little bit longer to be with our loved ones so we can recognize them—I’m all for it.”

What are the unintended effects of lecanemab?

The potential profit for Alzheimer’s sufferers is tempered by some warning from specialists about unintended effects associated to the medicine, together with irritation of the mind (which occurred in about 12.6% of individuals taking the medicine within the research) and bleeding in sure individuals. People who carry a genetic danger for Alzheimer’s within the ApoE gene are extra weak to the mind irritation, referred to as ARIA (amyloid-related imaging abnormalities), which may be detected with common mind scans and managed with cautious monitoring. The FDA’s approval consists of a warning to docs prescribing the drug in regards to the danger of ARIA.

Several individuals concerned within the drug’s trials have died, though researchers haven’t decided if lecanemab performed a position of their deaths. The danger of bleeding was detailed most just lately in a letter revealed within the New England Journal of Medicine on Jan. 4 by clinicians at Northwestern Feinberg School of Medicine. They described the case of a 65-year-old girl who had a genetic predisposition for Alzheimer’s and had participated within the Eisai examine. She had a stroke after finishing the 18-month examine—throughout which it’s not recognized if she obtained lecanemab or placebo—and was collaborating within the subsequent part of the trial by which all individuals obtain the drug. She had accomplished three doses when she got here to the emergency room with indicators of stroke. Brain scans confirmed that prognosis, and he or she was handled with an intravenous blood thinner referred to as tissue plasminogen activator. She later died.

Whether lecanemab contributed to the a number of mind bleeding occasions she skilled isn’t clear but, and Ivan Cheung, CEO of Eisai Inc, says the mortality amongst these receiving the drug within the research is akin to the speed amongst equally aged individuals within the basic inhabitants. But the case examine highlights the significance of cautious and thought of prescribing of lecanemab for sufferers—particularly these with genetic danger for Alzheimer’s, and people utilizing sure drugs to deal with different circumstances—that would doubtlessly work together with the drug. Blood-thinning remedies had been already recognized to work together negatively with anti-amyloid therapies like lecanemab.

Why Alzheimer’s drug remedies are historic—and controversial

Lecanemab is the second “disease-modifying” drug authorized by the FDA to deal with Alzheimer’s, which suggests it addresses one of many options—amyloid—of the illness. Other medication utilized in Alzheimer’s sufferers, akin to donepezil (Aricept) can decrease a number of the reminiscence signs of the the situation however don’t sluggish the gradual decline of mind nerve operate. The solely different authorized disease-modifying Alzheimer’s drug, aducanumab, which additionally targets amyloid, confirmed much less definitive profit amongst these taking it in comparison with lecanemab. The information that the FDA reviewed about that drug’s efficacy was conflicting, with one examine from Biogen, the drug’s developer, displaying optimistic outcomes and one other damaging, so docs and sufferers within the Alzheimer’s group haven’t embraced the drug regardless of its approval in June 2021.

Whether lecanemab faces the identical destiny stays to be seen, however specialists say the in depth and rigorous research Eisai carried out that led to the FDA’s resolution could give docs and sufferers extra confidence that lecanemab can sluggish the degeneration of neurons typical of Alzheimer’s. But it will likely be vital to match the drug to the sufferers who’re almost certainly to learn — these with early indicators of Alzheimer’s associated cognitive points. “I think it will require a change in the way Alzheimer’s is identified and diagnosed,” says Dr. Michael Irizarry, vice chairman of scientific analysis at Eisai Inc. With a drug like lecanemab, “it means physicians will have to evaluate for cognitive impairment earlier, and identify the cause of that impairment.”

Dr. Babak Tousi, head of the scientific trials program on the Cleveland Clinic Center for Brain Health (the place sufferers participated within the trial for lecanemab), says it’s vital to keep in mind that the drug doesn’t reverse harm to nerve operate within the mind, however slows down the method driving the illness, so such screening may establish extra individuals who may doubtlessly profit, and even result in larger enchancment over time. “It would be interesting to see if patients continue receiving the treatment for a longer period of time, whether they will see even more benefit compared to people not being treated,” he says. Fair, the affected person who participated within the trial, doesn’t know if he obtained the drug or a placebo in the course of the examine, however he’s now within the open-label a part of the trial and can get lecanemab over 18 months. He and his spouse don’t really feel his reminiscence points have worsened since his prognosis, and that’s an vital achievement. Like Fair, sufferers within the examine had been thought of to be within the early phases of Alzheimer’s and obtained the drug as soon as each two weeks for 18 months by infusion, which implies that any sufferers prescribed the drug might want to go to both their physician’s workplace or an infusion clinic for his or her doses.

How a lot lecanemab will price, and who can pay for it

Cost will likely be one other issue figuring out how nicely the drug is obtained. Aducanumab’s excessive worth of $56,000 a yr proved to be a deterrent, particularly when the Centers for Medicare and Medicaid Services (CMS) determined to not reimburse for the remedy except individuals obtained the drug as a part of a analysis examine. That resolution utilized to all future anti-amyloid therapies that obtained accelerated, and never customary approval, which now consists of lecanemab. The company has mentioned it could think about altering that coverage, however solely after the FDA grants full approval of lecanemab; Eisai’s Cheung says the corporate is at the moment engaged on submitting that request to the FDA for conventional approval.

CMS’s resolution could possibly be dangerous to Alzheimer’s sufferers, says Maria Carrillo, chief science officer on the Alzheimer’s Association. “We estimate that each day, more than 2,000 individuals over age 65 years transition from mild dementia due to Alzheimer’s to a more advanced stage where they are no longer eligible for [drugs like lecanemab],” she says. “That’s unacceptable. If we have to wait eight months or more [for coverage], then how many thousands of individuals will be rendered ineligible? We feel that’s wrong.” The Association submitted a request final December to CMS to rethink its coverage and start reimbursing for anti amyloid medication like lecanemab upon accelerated approval.

Reimbursement by insurers, who usually comply with CMS’s lead, will likely be essential for entry on this inhabitants. Eisai introduced that lecanemab would price $26,500 a yr initially. While that’s half of adcanumab’s price, it nonetheless places the remedy out of attain for many sufferers if it isn’t reimbursed.

Lecanemab—and different Alzheimer’s medication—are nonetheless being studied

Lecanemab was authorized below FDA’s accelerated approval course of, which permits the company to approve medication when there’s an unmet medical want—and with totally different requirements than are often required—if early security and efficacy info is compelling sufficient. In lecanemab’s case, Eisai’s strong part 2 research, which confirmed the 27% enchancment in cognitive expertise, had been sufficient for the FDA to think about the corporate’s request for approval, even whereas the final part 3 stage of testing continued.

The hope is that lecanemab’s success will spawn more practical anti-amyloid therapies, in addition to different remedies (concentrating on proteins like tau, for instance, that are can be poisonous in mind neurons) that together may maintain off probably the most damaging processes of the illness. If these therapies are began earlier in the midst of illness, earlier than signs of reminiscence loss or cognitive decline seem, it could be doable to keep away from the devastating results of neurodegeneration altogether. “We don’t have that yet, but that would be the ultimate goal,” says Gandy. Eisai can be conducting research of lecanemab in people who find themselves extra weak to growing Alzheimer’s, akin to these with sure genetic danger elements, however haven’t proven indicators of reminiscence or different cognitive signs but. The examine will present hints about whether or not it’s doable to delay and even forestall the illness altogether.

“I wouldn’t wish this [disease] on anybody,” says Fair. “I hope someday there’s a cure for [Alzheimer’s]. But you’ve got to take small steps in the beginning.”

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