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EMA approval for new drug to treat Alzheimer’s disease

A couple of weeks ago, the European Medicines Agency (EMA) gave the green light to the use of Lecanemab as a therapeutic option to try to slow the progression of a disease as prevalent and disabling as Alzheimer’s disease.

 

Although countries such as the United States, Japan, Israel, South Korea and the United Arab Emirates have started to use this drug, Europe has not decided to approve it until now, mainly because of its potential side effects, but also because of its modest clinical results in certain groups of patients, or the uncertainty towards its long-term results.

 

Lecanemab has proven to slow the progression of the disease by acting on the accumulation of amyloid plaques in the brains of patients. This accumulation is associated with the development of Alzheimer’s disease.

 

Approval by the European Medicines Agency is not free of conditions and restrictions, in order to ensure the safety and proper administration of the drug. Therefore, Lecanemab has been approved only for patients who meet the following criteria:

 

• Patients in early stages of the disease
• Confirmed amyloid pathology
• Carriers of one or no copies of the E4 allele of the ApoE gene.

 

In addition, all patients must undergo serial cranial MRI scans in order to assess and detect early potential adverse effects associated with the drug. This means that it can only be prescribed and administered by centres and doctors specialised in the management of Alzheimer’s disease.

 

However, this approval is only an intermediate step, as the use of Lecanemab in Spain still needs to be assessed and approved by the European Commission and other national bodies.

 

 

While it is still too early to know the efficacy and medium- and long-term effects of Lecanemab, new therapeutic approaches to a disease for which there is currently no cure, and whose incidence is growing due to the increasing longevity of the general population, are a very encouraging.

 

In Spain, 1 in 10 people over the age of 70 suffers from some type of primary dementia, with Alzheimer’s disease being the most prevalent. Its development causes the affected person to suffer a progressive deterioration in different cognitive functions, especially memory failures in terms of recent events, which has a significant impact on the quality of life and autonomy of the patient.

 

Dr. Nicolás Ciano
Neurologist at HC Marbella

 

 

Dezember 10, 2024

 

 

 

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