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04 Jul | 2024

A new drug approved in the United States to treat the initial stages of Alzheimer's

The FDA (U.S. Food and Drug Administration), the US drug regulatory agency, has approved the marketing of donanemab, a monoclonal antibody that attacks beta amyloid protein plaques 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, who have confirmation of the presence of these plaques in the brain.

The drug, which will receive the commercial name in the US of Kisunla, has been shown, according to the phase III clinical study carried out by the pharmaceutical company Eli Lilly and Company's, to reduce cognitive and functional decline by up to 35% compared to with placebo at 18 months, as well as participants' risk of progressing to the next clinical stage of the disease up to 39%.

Donanemab joins the approval a year ago in the United States of another drug that also slowed down the cognitive deterioration caused by the disease, lecanemab (trade name, Leqembi), which was shown to reduce amyloid markers and slow down the cognitive deterioration by 27% in patients in early stages of Alzheimer's.

"The approval of a second drug with these characteristics is good news since it reaffirms 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 Barcelona Beta 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.