(This is an abbreviated version of the FDA approval article).
Action
The U.S. Food and Drug Administration has approved Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease. Treatment with Kisunla should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in the clinical trials.
Kisunla is administered as an intravenous infusion every four weeks. The recommended dosage is detailed in the prescribing information.
Disease or Condition
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. 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. These changes affect a person’s ability to remember, think and speak.
Safety Information
The most common side effects of Kisunla were ARIA and headache.
See full prescribing information for additional information on risks associated with Kisunla.
Note: Talk with your neurologist to learn more about treatment efficacy, side effects and safety.
Source: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-adults-alzheimers-disease