The EMA decides to authorize Lecanemab against Alzheimer's at an early stage
None
The European Medicines Agency, the EMA, has decided to amend the evaluation of the medicine Leqembi (Lecanemab), which is available in Spain. Lecanemab is designed to treat mild cognitive impairment or early dementia caused by Alzheimer’ s disease, but due to its side effects, in July 2024, the EMA refused authorisation. The Committee for Medicinal Products for Human Use (CHMP) has now recommended that this should not be for all patients.
In particular, patients will only be allowed to have one or more copies of the ApoE4 gene, as this genetic variant significantly increases the risk of developing serious side effects, such as brain inflammation or bleeding.
In beneficial terms, during clinical trials, lecanemab showed that it slows down the progression of Alzheimer’ s symptoms by 27% compared to placebo. Treatment, however, requires strict measures. Patients should have MRIs performed before and during treatment to detect complications. In addition, the drug is not suitable for those taking anticoagulants, as there is a high risk of cerebral hemorrhage.
The EMA has established a controlled access programme to ensure that the drug is only administered in the recommended population. It also requires risk minimisation measures such as the training of healthcare professionals, patient warning cards and follow-up studies on the safety of treatment.
Leqembi is administered intravenously every two weeks. The CHMP recommendation will now be sent to the European Commission for final approval. Each Member State will then decide how it will offer within its health system.
Therefore, the protection of EMA represents a significant advance in the treatment of Alzheimer’s, but considering that it is limited to a certain group of patients to ensure benefits and avoid serious side effects.
Zu idazle
Zientzia aldizkaria
