- For Print
- November 29, 2022
(The news release "ARTICLE REGARDING SAFETY INFORMATION OF LECANEMAB PUBLISHED IN THE AMERICAN SCIENTIFIC JOURNAL SCIENCE" disclosed on November 29, 2022 has been corrected due to an error in the name of media in which the article was reported.)
First and foremost, we are incredibly grateful to all the patients and their families for their participation in Eisai’s lecanemab clinical trials. The well-being of the patients enrolled in our clinical studies is always Eisai’s top priority.
Eisai has established a rigorous safety monitoring process to ensure patient safety. This includes an independent data safety monitoring committee of external experts. All the available safety information indicates that lecanemab therapy is not associated with an increased risk of death overall.
Eisai promptly communicates important safety information to regulatory agencies, sites, investigators, and subjects through a variety of appropriate mechanisms including investigator communications, Independent Review Board (IRB) communications, and Informed Consent Form (ICF) revisions.
Eisai will present the full results, including consistent safety data, from the Phase 3 confirmatory Clarity AD clinical trial to the Alzheimer’s disease community at the Clinical Trials on Alzheimer’s disease on November 29, 2022.
Public Relations Department,
Eisai Co., Ltd.