What's the mechanism of action for Leqembi (lecanemab-irmb)?
Leqembi is an anti-Aβ (amyloid-beta) protofibril antibody and has been shown to reduce brain amyloid and modestly slow cognitive decline in adult patients with early Alzheimer disease. It is thought to slow down the progression of Alzheimer’s by neutralizing and eliminating the toxic amyloid-beta aggregates found in the brain.
The accumulation of amyloid plaques in the brain is a defining feature of Alzheimer disease.
Timeline for Leqembi approval
In July 2023, the FDA granted traditional approval of Leqembi (lecanemab-irmb) from Eisai / Biogen. It is the second intravenous (IV) amyloid beta-directed monoclonal antibody to treat patients with Alzheimer disease with mild cognitive impairment (MCI) or mild dementia.
Aduhelm (aducanumab), approved in June 2021, was the first approved IV amyloid-beta directed monoclonal antibody.
Does Leqembi work? Studies for Leqembi
Studies have shown that Leqembi reduces brain amyloid plaques and slows disease progression in early Alzheimer disease.
CLARITY AD study (Study 301)
The Phase 3, global, placebo-controlled confirmatory CLARITY AD study (Study 301) included 1,795 participants with mild cognitive impairment or mild dementia stage of disease and confirmed presence of amyloid beta pathology. Patients received placebo or Leqembi at a dose of 10 milligrams (mg)/kilograms (kg), once every two weeks.
Treatment of patients with Leqembi met the primary endpoint, which was reduction from baseline in cognition and function as measured by the Clinical Dementia Rating–Sum of Boxes (CDR-SB) by 27% compared with placebo (1.21 with lecanemab and 1.66 with placebo [difference, -0.45; 95% CI -0.67 to -0.23; P<0.001) at 18 months. Results started as early as 6 months. CDR-SB is a numeric scale used to quantify the various severity of symptoms of dementia.
A subgroup analysis also showed significant reductions in brain amyloid at 18 months vs. placebo. Other key secondary endpoints, like the Alzheimer’s Disease Assessment Scale Cognitive Subscale 14, and the Alzheimer’s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment were also met.
How is Leqembi given?
Leqembi is given into your vein through a needle placed into your arm by a healthcare provider (IV infusion). Before starting treatment with Leqembi, your healthcare provider will confirm the presence of brain amyloid.
The recommended dose is 10 mg/kg given once every two weeks as a one-hour intravenous (IV) infusion. It is given every 2 weeks and each infusion will last about 1 hour. You will need to spend additional time at the infusion clinic.
Your doctor may give you medicine (antihistamines, steroids) before your Leqembi infusion to help prevent infusion-related side effects. Infusion-related side effects can include: fever, nausea, vomiting, chills, dizziness, lightheadedness, changes in your heart rate, or shortness of breath.
What is ARIA with Leqembi?
Leqembi has an important warning for Amyloid Related Imaging Abnormalities (ARIA). ARIA is a side effect that does not usually cause any symptoms, but serious symptoms may occur. Your healthcare provider will check you for ARIA before and during treatment with a magnetic resonance imaging (MRI) scan.
Some people may have a genetic risk factor (homozygous apolipoprotein E gene carriers) that can increase the risk for ARIA. Talk to your healthcare provider about testing for this risk factor.
How often does ARIA occur with Leqembi?
Phase 2 Study
In the Phase 2 accelerated approval studies, the most common side effects (at least 10% incidence) included:
ARIA is swelling in areas of the brain, with or without small spots of bleeding in or on the surface of the brain (ARIA). ARIA-E resolved in 94% of patients. Most ARIA-E side effects seen on an MRI occurred within the first 7 doses, but ARIA can occur at any time and frequency.
The risk of ARIA was greater in patients who are ApoE4 homozygotes compared to heterozygotes and noncarriers. Your doctor may test you for ApoE4 status prior to starting treatment.
Phase 3 Study
In the Phase 3 study CLARITY AD, symptomatic ARIA-E occurred at 2.8% of patients receiving Leqembi vs. 0% of patients on placebo. The total incidence of ARIA (ARIA-E and/or ARIA-H) was 21.3% in the Leqembi group and 9.3% in the placebo group.
In initial studies, 15% of patients treated with Leqembi vs. 6% of patients on placebo stopped treatment because of a side effect (most commonly infusion reactions, 2% vs. 1% placebo). For infusion reactions, premedication may be needed.
Be sure to tell your healthcare provider if you take medicines to reduce blood clots from forming (antithrombotic medicines, including drugs like warfarin or aspirin). Ask your healthcare provider for a list of these medicines if you are not sure.
How much does Leqembi cost?
The price of Leqembi is $26,500 per year, slightly below the $28,200 annual cost of Aduhelm. Leqembi became commercially available from Eisai on January 18th, 2023.
Eisai offers a Patient Support Program and Copay Assistance Program that can help you determine and navigate your insurance coverage and answer any questions you or your doctor may have. To learn about the Eisai Patient Support Program for patients prescribed Leqembi, you can call 1-833-4-LEQEMBI (1-833-453-7362) or access the information online.
This is not all the information you need to know about Leqembi (lecanemab-irmb) for safe and effective use and does not take the place of your doctor’s directions. Review the full Leqembi information and discuss this information and any questions you have with your doctor or other health care provider.
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