Alzheimer's: Leqembi® halted in France

The French National Authority for Health (HAS) has rejected the request for early access to Leqembi® (lecanemab), the first treatment targeting amyloid deposits associated with Alzheimer's disease. While this drug, developed by Biogen and Eisai, had raised high hopes by promising to slightly slow cognitive decline, the institution believes that the actual clinical benefit remains "very insufficient" and difficult to perceive for patients, limited to a few months of respite.

The HAS also points to a worrying safety profile: risks of cerebral edema, micro-hemorrhages and even fatal hemorrhages, as well as a particularly cumbersome protocol. The treatment requires infusions every two weeks, regular MRI monitoring and genetic testing to identify at-risk patients, all at a cost considered exorbitant.

While the United States and the European Union have already given the green light, France is opting for caution. This caution is seen by some as a necessary safeguard against scientific uncertainty, but is denounced by the Vaincre Alzheimer Foundation as "immense hope gone" for patients and their loved ones. The association also warns against sending a negative signal to French medical research, which could lose its appeal for future clinical trials.