Expanding the Knowledge Profile and Treatment Capabilities of Lecanemab: Lynn Kramer, MD, FAAN

In August 2023, the FDA granted traditional approval to Eisai’s lecanemab (Leqembi) as a new therapy for patients with Alzheimer disease (AD) after it received accelerated approval earlier in the year. Lecanemab, a humanized monoclonal antibody that eliminates toxic amyloid-ß protofibrils, considered a hallmark of AD pathology, was approved based on data from the phase 3 Clarity AD trial (NCT03887455). With its approval, lecanemab became only the second early AD treatment to receive FDA approval in the past 20 years following the contentious—and now removed—aducanumab (Aduhelm; Biogen) in 2021. More recently, in early July, Eli Lilly’s donanemab (Kisunla) became the next to join the class of antiamyloid treatments.

As expected, the incorporation of these therapies into clinical care takes some time, especially considering the significant ways testing for AD has changed over the years. Now, patients are required to show positive evidence of amyloid in the brain, indicated through PET scan, instead of completing traditional cognitive tests that characterize symptoms. As society continues to age, the number of patients eligible for these treatments are expected to grow, and with that, the understanding of how to use these treatments effectively, remains of the utmost importance.

At the 2024 Alzheimer’s Association International Conference (AAIC), held July 28-August 1, in Philadelphia, Pennsylvania, Eisai presented several different posters related to lecanemab, including new 36-month data from Clarity AD and its open-label extension. During the conference, Lynn Kramer, MD, FAAN, chief medical officer at Eisai, sat down to discuss how the knowledge profile of the lecanemab has grown since its approval, and the importance of administering it at the earliest stage of AD. Kramer, an expert in the field, discussed some of the ongoing studies of lecanemab to further its efficacy and safety profile, as well as how a new maintenance dosing and subcutaneous administration route may continue to provide more treatment flexibility for eligible patients.