Recently released data from Eisai’s Phase 3 clinical trial of lecanemab shows that the drug slowed the rate of cognitive decline by 27% as compared to the placebo group in an 18-month study of participants experiencing the early stage of Alzheimer’s disease. Lecanemab finds and removes amyloid plaque that builds up in the brain of those with Alzheimer’s disease. Many researchers believe that the accumulation of beta-amyloid in the brain is the primary suspect in beginning the process that destroys nerve cells leading to Alzheimer’s.
The study results represent topside data released directly by Eisai. There will be much more data presented in November at the Clinical Trials in Alzheimer’s Disease meeting, including data on safety, as well as publication of the data in a peer-reviewed journal. If all goes well, lecanemab could receive FDA approval as early as January 2023.
“These clinical trial results are very exciting and give much needed positive news that should bring renewed hope to persons with Alzheimer’s disease and their families in New Jersey and beyond,” said Ken Zaentz, President and CEO of Alzheimer’s New Jersey. “Results like these also point to the importance of participation in clinical trials as we continue to pursue research to delay onset, prevent and cure this dreaded disease. At the same time, it is important for families to understand that lecanemab is not meant to be a cure for the disease and, even if approved by the FDA, may not be the right drug for everyone who has Alzheimer’s.”
“If the data review continues to support these encouraging results, however, we hope the FDA will move quickly to approve it. We then hope that the Centers for Medicare and Medicaid Services (CMS) will base its national coverage determination on the individual lecanemab data and not on its previous decision limiting coverage of all monoclonal antibodies that target amyloid.”
For additional information please contact the Alzheimer’s New Jersey Helpline at 888- 280-6055 or visit www.alznj.org.
