The US Food and Drug Administration (FDA) has approved donanemab, a drug for Alzheimer’s disease, for people in the US with confirmed amyloid positivity and a diagnosis of mild cognitive impairment (MCI) or early-stage Alzheimer’s disease.
Donanemab is an antibody-based treatment intended to remove amyloid. It is given as an infusion into a person’s arm every four weeks and can be stopped after amyloid plaque is removed to minimal levels. Donanemab is, however, associated with side effects and US clinicians have been warned to monitor for amyloid-related imaging abnormalities (ARIA) which can be seen on MRI scans.
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is conducting a review of the donanemab data, and The National Institute for Health and Care Excellence (NICE) need to evaluate its cost-effectiveness.
Read about the FDA decision here: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-adults-alzheimers-disease
Find out more about Donanemab here: https://www.alzheimersresearchuk.org/news/new-alzheimers-drug-donanemab-what-is-it-and-how-does-it-work/