The European Medicines Agency (EMA) has approved Leqembi, a new treatment for Alzheimer's disease, aimed at reducing cognitive decline in patients with mild cognitive impairment or mild dementia. This decision comes after the EMA initially blocked the treatment in July due to concerns over serious side effects, including potential brain bleeding. The EMA has now recommended Leqembi only for patients at lower risk of such side effects, specifically those with one or no copies of the ApoE4 gene, which is linked to Alzheimer's risk.
Leqembi, developed by Eisai and Biogen, was first authorized in the United States in January 2023 and is also available in Japan and China. The treatment is administered intravenously every two weeks and has been shown to reduce amyloid plaques in clinical trials, which are believed to contribute to the progression of Alzheimer's disease. Despite decades of research, effective treatments for Alzheimer's have remained elusive, impacting millions globally.