The pharmaceutical company Lilly has presented in the framework of the AAIC (Alzheimer's Association International Conference) complete results of its study in phase III TRAILBLAZER-ALZ 2 that show that donanemab, a monoclonal antibody that is directed against amyloid plaques, slows down by 36% cognitive and functional impairment in people with early symptoms of the disease.
According to the results presented, and simultaneously published in JAMA, donanemab treatment significantly reduced amyloid plaque levels. The investigational drug reduced amyloid plaque at 18 months by an average of 84% of participants, compared with a 1% decrease in participants receiving placebo. Almost half of the study participants who received the drug had no clinical progression after one year.
The authorization request for donanemab to the North American regulatory agency, the FDA (U.S. Food and Drug Administration), has already been requested and a resolution is expected to be reached by the end of this year. Just a few days ago, the FDA gave the green light for the commercialization in the United States of lecanemab, a drug developed in this case by the pharmaceutical companies Biogen and Eisai, for the treatment of mild cognitive impairment and dementia due to Alzheimer's disease.