The Memory Unit of the Neurology Service at Hospital Sant Pau expresses great satisfaction with the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation of lecanemab for treating early-stage Alzheimer’s. This decision follows the reconsideration of the initial evaluation during the appeals process.
Hospital Sant Pau, together with other Spanish centers, participated in the Phase 3 study of lecanemab, a pivotal investigation that enabled this recommendation. Following the model established in the United Kingdom, the drug’s use is limited to a subgroup of patients based on safety and efficacy data. Patients on anticoagulants and those carrying two copies of the APOE4 allele are excluded from treatment.
Despite these restrictions, this recommendation represents a historic milestone in the fight against Alzheimer’s, as lecanemab is the first drug capable of slowing the disease’s progression. Furthermore, its introduction into clinical practice marks a new paradigm in treating this fatal condition, which has until now been diagnosed in its early stages only in certain specialized centers. This approval will not only facilitate access to new diagnostic techniques but also drive the development of treatments for Alzheimer’s and other neurodegenerative diseases, as seen with fibrinolysis and the creation of stroke units or advancements in managing multiple sclerosis.
“The EMA’s recommendation marks the beginning of a new care model for people with Alzheimer’s,” highlights Juan Fortea, head of the Neurobiology of Dementias research group at the Sant Pau Research Institute (IR Sant Pau) and director of the Memory Unit at Hospital Sant Pau. “This new phase will require the implementation of biomarkers, training for specialized professionals, and increased resource allocation to ensure comprehensive and innovative care that can, for the first time, change the clinical course of the disease.”
The EMA’s decision also corrects an initial stance that left Europe at risk of lagging in global Alzheimer’s research. With this resolution, the European Commission will need to determine marketing authorization for the entire European Union. Once approved, each member state must define the treatment’s pricing and implementation based on their healthcare system’s characteristics, a process that may take 1 to 2 years.
While this approval is not the end goal, it represents a crucial first step toward improving the quality of life and future of individuals affected by this disease.
