The Ema Agency has finally approved the Lecanemab monoclonal antibody. It will be useful to those suffering from Alzheimer’s early phase.
With the approval also in Europe of Leqembo® (Lecanemab)first drug that succeeds in Slow down Alzheimera new course opens for those suffering from this terrible pathology. After a significantly complicated path, finally the April 15, 2025 theHemaThe European drug agency, gave the green light to the use of this Monoclonal anti-plaque antibody-amyloid antibodywhich in the United States is already used by the first months of 2023.
The drug is suitable for adult patients in the early phase of the diseasetherefore with still mild dementia and light cognitive deterioration. Leqembre, produced by the partnership between the Japanese pharmaceutical house Eisai and the American Biogenaffects the amyloid plaque that deposits in the brain and also the proteins that they have not yet deposited.
Only the sick who can take it that are not carriers of the APOE4 genewhich makes at greater risk of incurring the appearance of cerebral edema or bleeding: The removal of the amyloid protein can in fact lead to an alteration of the vascular structures, and the drug is therefore contraindicated for those who are at risk of meeting these problems.
It certainly does not represent “The perfect drug” Against Alzheimer that the world has been waiting for too many years, but – together with another antibody, the donanemabstill not approved in Europe but already administered all over the world, from the USA to Japan to Korea to the United Kingdom – is the first to demonstrate a slowdown of the diseaseand therefore it is The first great hope to be able to act positively on the life of the sick.
The challenges still open between costs, side effects and accessibility
«The European approval of Lecanemab represents a Significant step forward in the fight against Alzheimer – says Professor Massimo Filippidirector of the unit of neurology, of the service of neurophysiology and the unit of neurory and ordinary neurology at theVita-Salute San Raffaele University – our Center is committed to guaranteeing safe and timely access to these new therapies, through a structured path that includes early biological diagnosis, evaluation of risk factors And continuous monitoring of effectiveness and safety of the treatment “.
Now it will be necessary to wait for the assessments of theItalian regulatory agency, AIFAalso to understand what the prescription and reimbursement methods of the drug.
The treatments are in fact very expensive: we talk about about 25,500 dollars for the treatment of one year of lecanemab e 32,000 For that of Dadanemab. In addition, the scientific community is also located in front of the ethical and clinical dilemma to understand if and how useful it is to treat patients with drugs they have important side effects“Only” to get a slowdown of the disease.
The 22% of those who took Lecanemab, in fact, developed symptoms attributable to cerebral edema or micro bleeding. In most cases these side effects have been mild and without consequencesbut in 3% instead they caused serious problems.
“If AIFA also approves this new drug – explains Professor Paolo Calabresiordinary of neurology atCatholic Universitycampus of Rome and director of the neurology department of IRCCS Polyclinic Gemelli – It will be necessary to understand if i benefits will also be relevant from a clinical point of viewin Real Worldand above all in terms of quality of life of patients. In fact, they will be just Theytogether with theirs family membersto determine or not the final success of these therapies “.
