EU approves Kisunla drug for Alzheimer's with reservations

Last week, the European Union authorized the marketing of Kisunla, a drug produced by the American company Eli Lilly, for the treatment of mild cognitive impairment and early dementia caused by Alzheimer's disease. According to AFP, the decision comes after an initial refusal by the European Medicines Agency (EMA), and is accompanied by strict conditions of use. Kisunla, based on the molecule Donanemab, is the second treatment of this type approved in Europe, after Leqembi (Lecanemab), developed by Biogen and Esai.

• Hopes and limits

After decades of unsuccessful efforts, the two drugs have demonstrated for the first time a slowdown in the deterioration of patients' condition. However, the effects are considered moderate, and part of the medical community disputes their real usefulness. "These therapies bring hope, but also a wave of skepticism. We cannot yet speak of a radical change in the treatment of Alzheimer's," warn the specialists, quoted by AFP.

• Serious risks for patients

In addition to limited benefits, Kisunla and Leqembi are associated with serious, sometimes fatal side effects - in particular hemorrhages and cerebral edema. For this reason, Kisunla can only be administered to patients at the beginning of the disease and who do not have genetic mutations that increase the risk of complications.

• Reimbursement, decision at national level

The European Commission has left the member states free to decide whether and under what conditions they will reimburse the treatments. In France, the authorities have so far refused an accelerated procedure for the reimbursement of Leqembi, citing an unsatisfactory cost-benefit ratio.

In the United Kingdom, the treatments have been authorized, but are not reimbursed, and in the United States the decision on the coverage of the costs depends on private insurance companies.

• Between progress and caution

The approval of Kisunla marks a new step in the fight against Alzheimer's, but also confirms the tension between innovation and caution in the medical field. Although these treatments could represent the beginning of a new therapeutic era, their real impact on patients remains a matter of debate.