Alzheimer’s. New hopes for the fight against the disease. Pharmaceuticals Eisai and Biogen have announced the results of a phase III study which shows that the experimental molecule lecanemab, administered in the early stages of the disease, reduces the progression of Alzheimer’s by 27%.
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The companies anticipated that they plan to submit the dossiers for approval of the drug to the European Medicines Agency by March 2023. Lecanemab is a monoclonal antibody that recognizes and eliminates beta-amyloid aggregates, the major constituent of the characteristic plaques of the drug. Alzheimer’s. The trial (called Clarity AD) involved 1,795 people with mild cognitive impairment due to Alzheimer’s and mild Alzheimer’s who were followed for 18 months after starting the drug. Compared to the control group that received a placebo, patients treated with lecanemab showed a 27% reduction in cognitive decline, as measured by an appropriate rating scale called CDR-SB. The study also documented a reduction in the amount of beta-amyloid in the brain.
NEW DATA: Topline data from the confirmatory Phase 3 CLARITY AD trial is now available for our investigational anti-amyloid-beta protofibril antibody. #Alzheimersdisease
— Eisai US (@EisaiUS) September 27, 2022
Overall, the side effects were considered to be in line with expectations. For Haruo Naito, CEO of Eisai, “these results will create new horizons in the diagnosis and treatment of Alzheimer’s disease”. Furthermore, the study has an important scientific value since it confirms that “the abnormal accumulation of beta-amyloid in the brain is one of the main causes of Alzheimer’s disease,” he added. “Today’s announcement gives patients and their families hope that lecanemab, if approved, could potentially slow the progression of Alzheimer’s disease and provide a clinically meaningful impact on cognition and function,” added Michel Vounatsos, administrator. delegate of Biogen.