The drug, Leqembi, is approved specifically for patients with mild or early Alzheimer’s.
Based on early results
The drug is likely to only help for a few months, but can still improve people’s lives in a meaningful way as it can slow down the progression of the disease.
The approval of Leqembi, which was developed by the American pharmaceutical company Biogen and Japan’s Eisai, is a so-called rapid approval and is based on early results.
Side effects
Full trial data, published in the New England Journal of Medicine, have raised concerns about the incidence of side effects. This applies above all to an increased risk of brain haemorrhages and brain swelling.
Last week, a congressional report criticized the FDA’s fast-track approval of Aduhelm, a similar Alzheimer’s drug from the same drug company, for irregularities in the process. Among other things, meetings with pharmaceutical company representatives have not been documented.