On January 6, 2023, the Food and Drug Administration approved the new Alzheimer’s drug lecanemab, which has been shown in clinical trials to slow cognitive decline in patients with mild cognitive impairment or early Alzheimer’s disease. The approval offers patients renewed hope after repeated failures to find effective treatments.
The announcement came following a highly critical congressional report detailing the approval of a different Alzheimer’s drug in 2021, called Aduhelm. That drug, developed by Biogen, was approved quickly two years ago despite an FDA advisory committee’s finding that it was unlikely to work. Scientists have more confidence in lecanemab, however. According to the researchers at the University of California San Francisco, “Aduhelm has a similar mechanism to lecanemab, but it targets a different version of amyloid beta and is less effective at removing amyloid beta at its recommended dose.” Two large trials of Aduhelm in early symptomatic Alzheimer’s disease were discontinued prematurely, and one trial did not show a benefit in symptoms, whereas trials of lecanemab proved that it slowed cognitive decline by 27 percent.
The Approval of Lecanemab
Alzheimer’s is the seventh leading cause of death in the United States, according to the Centers for Disease Control and Prevention. Most drugs approved by the FDA for Alzheimer’s are aimed at helping symptoms, not actually slowing the progression of the disease. In a clinical trial, lecanemab was shown to be effective in slowing cognitive decline for some patients with the disease, potentially representing the first significant treatment advance in decades.
Detailed results from the clinical trial involving lecanemab were published in the New England Journal of Medicine. The clinical trial followed nearly 1,800 participants for 18 months, finding that the drug slowed cognitive decline in people who received it by 27 percent, as mentioned. According to the study’s authors, the drug “resulted in moderately less decline on measures of cognition and function,” particularly in patients in the early stages of the disease with mild cognitive symptoms.
Lecanemab was approved in an accelerated pathway, which allows early approval for promising new medications that “fill an unmet medical need.” The FDA did not seek the advice of its advisory committee — which it did do before with Aduhelm. Although it is already approved, companies are required to conduct additional clinical trials to confirm the benefits of their drugs or risk their removal from the market.
Advocacy Group Objects to the Approval
Public Citizen, an advocacy group, urged the FDA to postpone its decision on whether to approve the drug while the companies finish the additional clinical trials needed for full approval. The Alzheimer’s Association disagreed, stating that based on the Eisai and Biogen (the companies that developed the drug) clinical trial results, the FDA should approve the drug for early-stage Alzheimer’s. Donna Wilcock, the assistant dean of biomedicine at the University of Kentucky, agreed, stating that the data supporting lecanemab’s application is “robust.” She added that the results of the trial are the best she has “ever seen for an Alzheimer’s drug in my 25 years.”
Despite some objections, the drug was approved and will be administered to a limited number of patients participating in a registry study. The agency said its decision was based on a mid-stage trial of 856 patients with Alzheimer’s disease. Eisai and Biogen believe that the FDA will likely give full approval based on clinical benefit in about 9 months.
What You Should Know About Lecanemab
Results of the clinical trial described showed that lecanemab produced a clear yet modest clinical benefit for people in the early stages of Alzheimer’s. In comparison with a placebo, the drug slowed the rate of cognitive decline over 18 months and reduced the levels of brain amyloid. Here are more things you should know about lecanemab.
- Lecanemab is not a cure; it aims to slow the progression of the disease by removing clumps of beta-amyloid — long thought by scientists to be one of the main causes of the disease — from the brain.
- The drug will be sold under the name Leqembi and will be administered as a monoclonal antibody infusion given every two weeks.
- The biweekly medication is expected to cost around $25,000 annually for a single patient. The Centers for Medicare & Medicaid Services (CMS) currently limits coverage of drugs that target amyloid in the brain, so coverage of the new medication may be limited at first. “CMS is examining available information and may reconsider its current coverage based on this review,” the agency said.
- Lecanemab should not be used in patients diagnosed with other conditions that cause cognitive impairment and dementia (e.g., Lewy body dementia, vascular dementia, frontotemporal dementia, or Parkinson’s disease).
- Before drugs like lecanemab can be considered for use, a doctor must detect evidence of brain accumulation of Alzheimer’s disease proteins with either a lumbar puncture or an amyloid beta positron emission tomography (PET) scan of the brain.
The benefit is small, experts say, but added anything that might give patients additional time with family and other loved ones is valuable. Making the drug more widely available could mean more patients have “many months more of recognizing their spouse, children and grandchildren,” said Maria Carrillo, the chief science officer for the Alzheimer’s Association.
Side Effects of the Drug
It is important to note that the clinical trials also showed that 12.5 percent of participants who took lecanemab experienced brain swelling, which has been observed in other experimental drugs that target amyloid beta. According to researchers, the swelling was not life-threatening and was resolved over several weeks when the medication was temporarily halted. Researchers also saw a higher rate of microhemorrhages, or “pinhead bleeds,” that are often seen in patients with Alzheimer’s disease, so they caution that the treatment requires careful clinical and MRI monitoring, particularly in the first six to 12 months.
People who carry a specific gene version called APOE-ε4 experience a higher risk of side effects from lecanemab. Testing for this gene is highly recommended for everyone who is being considered for lecanemab treatment. Despite the side effects, Eisai and Biogen are still “confident” that the benefits of the drug outweigh its risks.
Also, it’s important to know that three people who participated in the clinical trial have died. Recently, a third patient death potentially was tied to lecanemab in the phase three extension study, according to a report from Science. The latest death was attributed to brain swelling and bleeding, as well as seizures. The patient was a 79-year-old Florida woman who was participating in the phase three trial. The previous two deaths were attributed to a common side effect of this class of drugs called amyloid-related imaging abnormalities, or ARIA, which are abnormalities that show up in MRI imaging and can signal bleeding in the brain or swelling. Eisai and Biogen said in their statement that the rate of deaths in the lecanemab trial were similar to the placebo group and does not suggest an increase in deaths overall.
We will keep our readers up-to-date as more information becomes available about lecanemab.
Planning for a Loved One with Alzheimer’s
If you have a loved one who suffers from Alzheimer’s or another form of dementia, it’s important to plan in advance. Those with Alzheimer’s and their families face special legal and financial challenges. At the Farr Law Firm, we are dedicated to easing the financial and emotional burden of individuals suffering from degenerative diseases and their loved ones.
If you or a family member are facing a diagnosis of Alzheimer’s or another form of dementia, please call us to make an appointment for an initial consultation to discuss life care planning and asset protection in connection with obtaining Medicaid and Veterans special pension benefits:
Medicaid Planning Attorney Fairfax, VA: 703-691-1888
Medicaid Planning Attorney Fredericksburg, VA: 540-479-1435
Medicaid Planning Attorney Maryland: 301-519-8041
Medicaid Planning Attorney Washington, DC: 202-587-2797
About Evan H Farr, CELA, CAP
