The drug, lecanemab, slowed progress of the disease by 27% compared with a placebo, meeting the study's main goal, and potentially offering hope for patients and their families desperate for an effective treatment.
"That's an enormous advance in and of itself beyond the symptomatic medications that we've been using to date," added Dr. Lawrence Honig.
The Phase III trial evaluated the drug's ability to reduce cognitive and functional decline based on the Clinical Dementia Rating-Sum of Boxes (CDR-SB), a numerical scale used to quantify the severity of dementia in patients in areas such as memory, orientation, judgment, and problem-solving and personal care.
Eisai, leader of the 50-50 partnership's lecanemab program, is seeking FDA approval under an accelerated pathway, with a decision expected in early January.
It is aiming for full approval and commercialization of the drug in the United States, Europe, and Japan by the end of 2023, CEO Haruo Naito told reporters in Tokyo.
