Lecanemab is an amyloid beta-targeting antibody used to treat Alzheimer’s Disease in patients with mild cognitive impairment or mild dementia with a known amyloid beta pathology. It is for use in people who have only one or no copy of ApoE4, a certain form of the gene for the protein apolipoprotein E, and who have amyloid beta plaques in the brain.
In July 2022, the US Food and Drug Administration (FDA) accepted an application for accelerated approval for lecanemab.
In September 2022, Biogen announced positive results from an ongoing phase III clinical trial.
In November 2022, it was announced that the drug was a success in clinical trials, and exceeded its goal in reaching primary endpoints.
On January 6, 2023, lecanemab was granted accelerated approval by the FDA for the treatment of Alzheimer’s Disease. It was granted full FDA approval on July 6, 2023.
Safety and efficacy of lecanemab are known only for patients like those participating in the phase 2 and phase 3 lecanemab trials, and these AURs adhere closely to the inclusion and exclusion criteria of the trials. Adverse events may occur with lecanemab including amyloid related imaging abnormalities (ARIA) and infusion reactions. Most ARIA with lecanemab is asymptomatic, but a few cases are serious or, very rarely, fatal.
