The United States Food and Drug Administration (USFDA) on Tuesday approved a new Alzheimer’s drug from Eli Lilly. According to the drug regulator’s statement, the drug has shown in clinical trials to modestly slow a decline in memory and thinking abilities in people with the disease.
USFDA stated that treatment with donanemab, to be sold under the brand name Kisunla, should be initiated in patients with mild cognitive impairment or mild dementia stage of the disease.
The drug is a monoclonal antibody infusion given every four weeks. According to Lilly’s statement, Kisunla works by targeting amyloid in the brain, considered a hallmark of Alzheimer’s disease.
Alzheimer’s disease is an irreversible, progressive brain disorder affecting more than 6.5 million Americans that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks. Meanwhile, in India, an estimated 8.8 million Indians older than 60 years have dementia. In 2019, India ranked fourth globally in dementia cases, including Alzheimer’s. By 2050, it’s expected to become the second-highest, surpassing Japan and the United States.
While the specific causes of Alzheimer’s are not fully known, it is characterized by changes in the brain—including amyloid beta plaques and neurofibrillary, or tau, tangles—that result in loss of neurons and their connections, USFDA stated. These changes affect a person’s ability to remember, think and speak.
A report by NBC News revealed that this approval is significant as it adds another treatment option for the devastating disease. Interestingly, the results were similar to those seen with Leqembi.
According to the FDA, Kisunla also comes with potentially life-threatening side effects, which include brain swelling and brain bleeding. Although most cases identified in the trial were mild, three deaths were linked to the drug.
Kisunla is the second Alzheimer’s drug of its kind approved, behind Leqembi. A third drug — Biogen’s Aduhelm — was taken off the market this year, NBC reported.