Wednesday, July 12, 2023
Earlier this month, the Food and Drug Administration granted full approval to an experimental Alzheimer’s drug, lecanemab, after giving accelerated approval in January. Now begins the process, which could expand coverage to millions of patients.
“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” said Teresa Buracchio, acting director for the FDA’s office of neuroscience.
Eisai and Biogen’s lecanemab, which is marketed as Leqembi, showed modest success in slowing Alzheimer’s progression in clinical trials. However, there are some safety concerns linked to the use of the drug after three patients died during the clinical trials. Despite this, independent FDA advisers unanimously stated that Leqembi had a clinical benefit for treating Alzheimer’s.
For more information see Oriana González “FDA approves first drug to show Alzheimer’s progression” Axios, July 6, 2023.
Special thanks to Joel C. Dobris (Professor of Law, UC Davis School of Law) for bringing this article to my attention.