EMA Approves Alzheimer's Drug for Early Treatment: Ospedale San Raffaele Has Started Administering It

In its opinion upon reassessing its stance on the results of the Clarity-AD study, the CHMP concluded that the benefits of lecanemab in slowing cognitive decline associated with the disease outweigh the risks of side effects only in patients with one or no copies of the ApoE4 gene.

In this group, the risk of experiencing harmful side effects, such as cerebral edema and hemorrhage related to the presence of amyloid plaques typical of the disease, was lower than the risk observed in the overall study population, which included individuals with two copies of the ApoE4 gene.

Indications

As a result, the indication for lecanemab has been narrowed, excluding individuals with two copies of the ApoE4 gene, for whom the risk of cerebral edema and hemorrhage is higher.

The CHMP also mandated additional measures to mitigate risks, including a controlled access program and regular MRI scans to monitor the drug's safety.

These measures improve the benefit-risk profile of lecanemab, protecting those at higher risk from potential harmful side effects such as those mentioned above.

CARD - Center for Alzheimer's Disease and Related Disorders at Ospedale San Raffaele led by Professor Massimo Filippi, welcomes CHMP's positive decision.

CARD appreciates and supports EMA's considered approach to identifying patients most likely to benefit from treatment while excluding those at higher risk of harmful side effects, promoting timely, safe, and equitable access to these medications.

“The approval of lecanemab by EMA marks a historic moment in the treatment of Alzheimer’s disease. This drug offers new hope for all individuals affected by early-stage Alzheimer’s, enabling an intervention that could alter the course of the disease. It is a step forward that we, as neurologists and researchers, welcome with deep satisfaction,” states Professor Massimo Filippi, Head of the Department of Neurology and Neurorehabilitation at IRCCS Ospedale San Raffaele, and Professor of Neurology at Università Vita-Salute San Raffaele.

CARD Center at Ospedale San Raffaele

Prof. Filippi also highlighted the commitment of Ospedale San Raffaele, the first center in Italy to administer lecanemab since last summer, in full compliance with current regulations:
“Recognizing the value and challenges of this new therapy, our CARD Center has implemented a highly structured system to ensure the highest levels of safety and efficacy for patients.

We have introduced a program for early biological diagnosis, risk factor evaluation, and monitoring of efficacy and side effects, including regular MRI exams and a dedicated infusion service. This allows us to address patient needs effectively and minimize risks.

San Raffaele Hospital is ready to meet the challenges posed by these new treatments. Our experience with administering lecanemab demonstrates that we are fully operational and prepared to provide patients with the best available care," concludes Professor Filippi.

Alzheimer’s disease is a progressive neurological condition that affects brain functions, particularly cognition and memory. Currently, it affects approximately one million people in Italy. For this reason, CARD, the Center for the prevention, diagnosis, and treatment of Alzheimer’s disease, was established at San Raffaele Hospital last year.

The Center's goal is to provide a multidisciplinary clinical-instrumental check-up pathway to assess the risk of cognitive decline and implement prevention programs.

The Brain Health Check-up Program

Professor Federica Agosta, Group Leader of the Neuroimaging Unit for Neurodegenerative Diseases at Ospedale San Raffaele and Associate Professor of Neurology at Università Vita-Salute San Raffaele, states:
“In terms of early diagnosis and prevention, the Brain Health check-up program is active at San Raffaele. This new initiative, targeting people over 40, aims to promptly identify potential signs of cognitive decline through advanced clinical-instrumental examinations."