On January 6, 2023, the Federal Drug Administration (FDA) approved the Alzheimer’s drug Leqembi (lecanemab) via its Accelerated Approval Pathway program.
Leqembi has been found to slow cognitive decline in people with early-stage Alzheimer’s disease.
On this page are common questions and the PMC clinical team’s answers, as well as a recording of the PMC Community Discussion about Leqembi led by PMC Co-Directors Jason Karlawish, MD, and David Wolk, MD.
For specific questions regarding your condition or the condition of a loved one, please contact your physician or make an appointment with the clinicians at the Penn Memory Center. For other questions not answered here, please use our contact form or email email@example.com.
Click here to learn more about other disease-modifying therapies.
What’s Lecanemab and what’s next?
- Are we there yet with PET? Penn Memory Center
- FDA grants accelerated approval for Alzheimer’s disease treatment FDA.gov
- FDA gives green light to Leqembi, aka lecanemab Alzforum
- Dr. Karlawish answers common questions about Leqembi SciLine
- Dr. Karlawish warns of lecanemab safety concerns Science
- New Alzheimer’s Drug Shows Positive Results but Side Effects, The Wall Street Journal ($)
- Alzheimer’s drug shows modest success slowing declines in memory, thinking, NPR
- The science behind lecanemab, BioArtic AB
What is Leqembi (lecanemab)?
Leqembi is a drug developed by BioArctic AB, Biogen, and Eisai Co., Ltd. Leqembi has been found to slow cognitive decline in people living with early-stage Alzheimer’s disease. Lecanemab is the scientific name of the drug. It is marketed as Leqembi.
How does Leqembi work?
Patients with Alzheimer’s disease have a build-up of a particular protein, amyloid-beta, in their brains. Lecanemab is a human monoclonal antibody synthesized in a laboratory that selectively targets this build-up of amyloid-beta.
Studies show that lecanemab may slow down and reduce the build-up of amyloid-beta and positively impact a person’s ability to carry out day-to-day activities.
The FDA approved lecanemab via its accelerated approval pathway program, which expedites the approval of drugs for serious diseases based on a surrogate endpoint. The FDA considers amyloid positron emission tomography (PET) a suitable surrogate endpoint for clinically meaningful outcomes for Alzheimer’s disease drugs. However, some experts do not think amyloid PET is a measurement that is “reasonably likely” to predict clinical benefit for Alzheimer’s treatments.
How will Leqembi be administered?
The drug will be given as an hour-long intravenous (IV) infusion every two weeks.
How much does Leqembi cost?
Eisai has set Leqembi’s annual price at $26,500.
Currently, the Centers for Medicare and Medicaid Services (CMS) does not cover Leqembi. However, this determination may change in the future as CMS reviews new data about the drug.
Who will be eligible for Leqembi?
Individuals with mild cognitive impairment (MCI) or mild-stage dementia due to Alzheimer’s disease are eligible to receive Leqembi. This drug is not safe for people who are on blood thinners.
Patients will need to contact their physician or make an appointment with the clinicians at PMC to discuss specific health conditions and situations.
What are the side effects of Leqembi?
The main side effect of Leqembi is ARIA (Amyloid-Related Imaging Abnormalities). These are abnormalities caused by inflammation around blood vessels that can lead to local swelling of the brain and microhemorrhages in the brain. For the most part, ARIA is asymptomatic, but about 25% of these individuals have mild symptoms and a small number have more serious and permanent neurological outcomes. Additional side effects include hypersensitivity reactions, headaches, diarrhea and falls.
In a study of 1,800 participants, participants receiving the Leqembi were twice as likely to experience brain bleeding and swelling than those receiving the placebo.
Is Leqembi available at the Penn Memory Center?
Not yet. The Penn Memory Center is working with Penn Medicine to create a pathway forward for patients interested in Leqembi.
Is Leqembi FDA-approved?
Leqembi was approved by the FDA on January 6, 2023 using its Accelerated Approval Pathway program. This program allows the FDA to approve drugs that could be “potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit.”