EU authorizes first drug against Alzheimer’s

Brussels – Alzheimer’s: the European Union is writing a new chapter in its common health policy by authorizing, under strict conditions, the marketing of Leqembi, a drug to treat the disease in its early stage. It is the first drug of its kind authorized in the EU. Alzheimer’s disease affects the central nervous system. Degeneration of brain tissue results in the loss of brain cells, resulting in a progressive loss of cognitive and mental functions.

According to estimates, Alzheimer’s affects about 5 percent of the world’s population over the age of 65 and about 20 percent of those over the age of 85. However, early onset around age 50 can also occur. With an aging EU population, the European Union faces a potential whole new challenge to manage.

Alzheimer Europe, the non-governmental organization that aims to raise awareness of all forms of dementia, estimates that over 7.8 million men and women in the EU suffer from dementia, a figure that reaches over 9.7 million in Europe alone (EU countries plus non-EU European countries). The European Commission and Eurostat believe that deaths due to Alzheimer’s and dementia exceed 200 thousand each year, peaking at 265,386 deaths recorded in 2022. Numbers in hand, there is the equivalent of a country more populous than Bulgaria with central nervous system disease and one-third of Luxembourg’s population (661 thousand) dying each year.

The European Commission points out that Leqembi is a drug intended for people with only one copy or no copy of the ApoE4 gene. The ApoE4 gene is a variant of the apolipoprotein E (ApoE) gene, the strongest genetic risk factor for late-onset Alzheimer’s disease.

The European Medicines Agency (Ema) had already expressed a positive view on Leqembi in November. After evaluating the case and the agency’s green light, the European Commission felt it should follow up on the indications.