The FDA (US Food and Drug Administration), the American drug regulatory agency, has approved the marketing of donanemab, a monoclonal antibody that attacks the plaques of the amyloid beta protein that accumulate in the brain in the early stages of Alzheimer's disease.
This new drug receives the green light for the treatment of people with early symptoms of Alzheimer's such as mild cognitive impairment or mild dementia, which have confirmed the presence of these plaques in the brain.
The drug, which will be branded in the US as Kisunla, has been shown in a Phase III clinical study conducted by pharmaceutical company Eli Lilly and Company's to reduce cognitive and functional decline by up to 35% compared to placebo at 18 months, as well as the risk of participants progressing to the next clinical stage of the disease by up to 39%.
Donanemab follows the approval a year ago in the United States of another drug that also slows cognitive decline caused by the disease, lecanemab (trade name Leqembi), which was shown to reduce amyloid markers and slow cognitive decline by 27% in patients with early stages of Alzheimer's.
“The approval of a second drug of this nature is good news as it confirms that we will soon be able to begin to have a range of treatments that can slow the progression of the disease by eliminating amyloid plaques.”, says Dr. Arcadi Navarro, director of the Barcelonaβeta Brain Research Center and the Pasqual Maragall Foundation.
For now, donanemab can be marketed in the United States and We will have to wait for the possible resolution of the EMA, the European regulatory agency, which is currently reviewing the approval of lecanemab.
