Earlier this year, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lecanemab-irmb (Leqembi), one of the first disease-modifying drugs for Alzheimer’s disease. In July, the FDA granted full approval.
Accelerated approval is given to drugs that treat serious conditions and fill unmet medical needs, according to the FDA. Drugs are considered for full approval after the medications’ manufacturers conduct additional studies of their benefits.
In a phase 3 trial, lecanemab (pronounced “leh-CAN-uh-mab) demonstrated a modest—but significant—benefit in slowing cognitive decline in people with mild cognitive impairment or mild dementia due to Alzheimer’s. People with mild cognitive impairment have memory problems but can still manage day-to-day activities independently whereas those with dementia may need help with such tasks, as their memory and executive functioning are more severely affected.
Lecanemab is an antibody that reduces the accumulation of amyloid, a naturally occurring protein, that clumps together and forms plaques that collect between neurons and disrupt cell function in the brains of people with Alzheimer’s, according to the National Institutes of Health. Its approval follows that of aducanumab (Aduhelm), which also treats the underlying causes of Alzheimer’s disease and had been the only anti-amyloid monoclonal antibody on the market after it received accelerated approval in 2021. Aducanumab has not yet been granted full approval by the FDA.
A similar drug, donanemab, is in the pipeline. Results of a phase 3 trial published July 17 in JAMA showed that at one year the disease did not progress in 47 percent of people in the early stages of Alzheimer’s disease who took the drug, compared with 29 percent of those taking a placebo. It also cleared about 84 percent of amyloid from participants’ brains at 18 months. Eli Lilly, donanemab’s manufacturer, has filed for FDA approval.
We answered some common questions about lecanemab.
Are all patients eligible to take lecanemab?
Only people with signs of amyloid plaques and other symptoms of the early stages of Alzheimer’s disease are eligible. These signs are confirmed by PET scans or checking cerebrospinal fluid through a lumbar puncture.
How is lecanemab administered?
The drug is delivered via an intravenous infusion every two weeks at hospitals or infusion therapy centers. The infusions take about 45 to 60 minutes, according to the Alzheimer’s Association.
How much will lecanemab cost?
The drug’s manufacturers, Eisai Inc., and Biogen, estimated the drug would cost $26,500 per year, not including infusion costs, initial eligibility testing, or safety monitoring. The Centers for Medicare & Medicaid Services (CMS), however, said it will cover FDA-approved drugs like lecanemab for people who have been diagnosed with mild cognitive impairment due to Alzheimer’s or mild Alzheimer’s dementia and who have amyloid consistent with Alzheimer’s. Private insurers typically follow Medicare coverage but not always so be sure to discuss this treatment with your doctor and check with your insurance plan to see if it’s covered.
Additionally, CMS said doctors will be required to enroll eligible patients in a CMS-facilitated registry so the agency can continue to gather information about how the drug works. The Alzheimer’s Association recommends that patients ask their doctors about the drug’s availability, as manufacturing and distributing the drug will take time, and it has only just been approved.
What are the side effects of lecanemab?
Common side effects include headache, infusion-related reactions, and amyloid-related imaging abnormalities (ARIA), which can involve temporary swelling in the brain and small spots of bleeding in or on the brain. A more serious side effect is potentially fatal intracerebral hemorrhages.
Patients who have the APOE4 gene, one of the strongest risk factors for Alzheimer’s disease, are more likely than those who don’t have the gene to experience ARIA with swelling, small or large hemorrhages in the brain, or superficial siderosis, long-term chronic slow bleeding in the brain. Additionally, drug trial participants who took lecanemab with a blood thinner or with both a blood thinner and antiplatelet medication or aspirin had a slightly higher risk of intracerebral hemorrhage than those who were not taking these medications.
How does lecanemab compare to aducanumab?
Lecanemab is about $2,000 less expensive than aducanumab (Aduhelm), which costs $28,200 yearly, according to the manufacturer, Biogen. Both are delivered intravenously, although the infusion for aducanumab can take from one to three hours compared to the 45 to 60 minutes for lecanemab.
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