“New Alzheimer’s Drug, Lecanemab, Receives FDA Approval”

The U.S. The Food and Drug Administration (FDA), has approved a new drug for the treatment of Alzheimer’s disease in its early stages.

Lecanemab (which will be available under the name Leqembi) can slow the cognitive decline associated with Alzheimer’s disease by 27%. This is according to information provided to the FDA from the drug’s developers, Eisai & Biogen. This is only the second treatment to show any improvement in neurodegeneration. Neurodegeneration is a crucial criterion for FDA approval.

“We have been searching for this for a long time,” said Dr. Sam Gandy. He is a professor of neurology, psychiatry, and the director of the Mount Sinai Center for Cognitive Health (who wasn’t involved in the making or testing of the drug). “We would like to see more profit, but this is a good step.”

What’s lecanemab?
Lecanemab, the latest in a long line of medications that target amyloid (a protein that accumulates abnormally in the brains Alzheimer’s patients), is the most recent. It targets protofibrils, a form of amyloid that is extremely poisonous for the mind’s neurons. The drug attaches itself to these amyloid particles, preventing them from clustering together to form the plaques which can compromise nerve function.

While the 27% improvement in cognitive test scores between patients taking lecanemab and those receiving placebo after 18 months may not seem dramatic, the gradual decline could be sufficient to give sufferers additional months or even years with less memory issues.

This is important for people like Jerry Truthful who was diagnosed with Alzheimer’s disease in 2019. He took part in the Cleveland Clinic’s trial of lecanemab. He says, “It is not a miracle cure.” “But if we can slow [Alzheimer’s] down, if we have a bit more time to spend with our loved ones so that we acknowledge them, I’m for it.”

What are the unintended side effects of lecanemab?
Experts warn that the potential benefit for Alzheimer’s patients is mitigated by unintended side effects, including irritation of the brain (which happened in 12.6% of people taking the treatment in the study) and bleeding among certain individuals. Those who have a higher genetic risk for Alzheimer’s in the ApoE gene will be more susceptible to mind irritation (also known as ARIA, or amyloid-related imaging anomalies), which can be detected by regular mind scans. The FDA approved the drug with a warning for doctors prescribing it about the risk of ARIA.

Researchers have not determined if lecanemab was a factor in the deaths of some people who took part in trials of the drug. Clinical researchers at Northwestern Feinberg Faculty of Medicine published a letter in the New England Journal of Drugs dated January 4, detailing the risk of bleeding. The letter described a case of a girl aged 65 who was genetically predisposed to Alzheimer’s disease and participated in the Eisai study. After completing the 18-month study, it is not known if she received lecanemab as a placebo or not. She was also participating in the next part of the trial where all participants receive the drug. She was on her third dose when she went to the emergency department with symptoms of stroke. The analysis was confirmed by a brain scan, and the patient received an intravenous blood thinner called tissue plasminogen activater. She later died.

Ivan Cheung CEO of Eisai Inc. says that the mortality rate amongst those receiving lecanemab in the study is comparable to that of the general population of equally aged people. However the case research highlights the significance of cautious and regarded prescribing of lecanemab for sufferers–particularly these with genetic danger for Alzheimer’s, and people utilizing sure medicines to deal with different situations–that might doubtlessly work together with the drug. Lecanemab and blood-thinning medications have been known to interact negatively.

Why Alzheimer’s drug treatments are both historic and controversial
Lecanemab, the FDA’s second approved “disease-modifying drug” for Alzheimer’s disease, targets one of the many causes–amyloid. Alzheimer’s patients can take other medicines, such as donepezil or Aricept. These medications may reduce some of the symptoms of the condition but do not slow the decline in the function of the mind’s nerves. Acuranumab is the only other authorized Alzheimer’s disease-modifying drug. It targets amyloid and has shown a lesser benefit in comparison to lecanemab. FDA’s review of the efficacy of the drug was contradictory, with one study from Biogen’s drug developer showing positive results and another negative. As a result, doctors and patients in the Alzheimer’s community have not embraced it despite its approval by the FDA in June 2021.

Lecanemab’s fate is still to be determined, but experts say that the extensive and rigorous analysis Eisai conducted that led to FDA’s decision may give doctors and patients more confidence that lecanemab will slow the degeneration typical of Alzheimer’s. It will be important to select the patients who are most likely to benefit from the drug – those with early signs of Alzheimer’s related cognitive issues. “I think it will require a shift in how Alzheimer’s disease is diagnosed and recognized,” Dr. Michael Irizarry says, vice chair of medical research at Eisai Inc. “With a drug such as lecanemab,” physicians need to consider cognitive impairment sooner and determine the cause for this impairment.

Dr. Babak Tousi is the head of the medical trial program at the Cleveland Clinic Center for Mind Wellbeing (where patients participated in the lecanemab trial). He says that it is important to remember that the drug does not reverse damage to nerve function in the brain, but slows the process driving the disease. So, such screening could identify more individuals who would doubtless benefit, and may even lead to better improvement over time. It will be interesting to see whether patients who continue receiving treatment for a long time see more improvement than those not treated, says Dr. Babak Tousi. The patient who took part in the study doesn’t even know if they received the drug or placebo during the research. However, he is now in the open-label portion of the trial and will be receiving lecanemab for 18 months. His spouse and he don’t feel that his memory issues have gotten worse since his evaluation, which is a significant achievement. Patients in the study were also thought to be in the early stages of Alzheimer’s. They received the drug by infusion every two weeks over 18 months.

What will lecanemab be worth and who is able to pay for it?
The price will also have an effect on how well the drug is acquired. Aducanumab was expensive at $56,000 per year. This proved to be a barrier, especially when the Facilities for Medicare & Medicaid Companies (CMS), decided to withhold reimbursement until individuals obtained the medication as part of a research study. This call was made for all future antiamyloid treatments that received accelerated approval and not standard approval. Lecanemab is now included in this category. The company said it would consider changing that policy, but only after the FDA gives full approval to lecanemab. Eisai’s Cheung stated that the firm is currently working on submitting this request to the FDA for traditional approval.

Maria Carrillo is the chief scientist at the Alzheimer’s Association. She believes that CMS’s decision could be harmful to Alzheimer’s patients. She says that “we estimate every day more than 2,000 older people age 65 and over transition from mild dementia due to Alzheimer’s into a more advanced stage where they are not eligible for drugs like lecanemab”. “That’s unacceptable. How many people would be ineligible if we had to wait eight months for coverage? We feel this is flawed.” The Affiliation sent a request to CMS in December last year to reconsider its coverage, and to start reimbursing anti-amyloid medicines like lecanemab after accelerated approval.

Insurers, who generally follow CMS’s lead in this regard, must reimburse the cost of lecanemab to gain access to this population. Eisai announced that lecanemab will initially cost $26,500 per year. While this is half the cost of adcanumab, it still puts many patients out of reach if they are not reimbursed.

Lecanemab and other Alzheimer’s medicines are still being studied
Lecanemab has been approved under FDA’s accelerated process, which allows the company to approve medicines when there is an unmet medical need–and with different requirements than what are usually required–if the early safety and efficacy information is convincing enough. Lecanemab was approved under FDA’s accelerated approval course of, which allows the company to approve medicine when there is an unmet medical need–and with different requirements than are normally required-if early safety and efficacy info is compelling enough.

Lecanemab is expected to be a success, and this will lead to more effective anti-amyloid treatments, as well as other therapies (focusing on proteins such tau, which can also be toxic in the brain neurons), that may together prevent the most harmful processes of the disease. It may be possible to prevent neurodegeneration if these treatments are started earlier, before signs of memory loss or cognitive decline appear. Gandy says, “We haven’t reached that point yet but that is the ultimate goal.” Eisai is also conducting lecanemab research in individuals who are more susceptible to Alzheimer’s disease, such as those with certain genetic risk factors, but have not yet shown signs of memory or other cognitive symptoms. The study will provide hints on whether it is possible to delay or even stop the disease.