Last April 22, the National Health Surveillance Agency (Anvisa) approved the use of Donanemabe, an innovative drug for the treatment of Alzheimer’s disease in early stages. Considered an advance, it is immunological therapy that aims to reduce protein deposits in the brain associated with the condition.
Alzheimer’s disease is the most common form of dementia – it represents about 70% of cases. In Brazil, the scenario is especially worrying: according to the National Report on Dementia (RENADE), released in September 2024 by the Ministry of Health, eight out of ten patients are not diagnosed and, consequently, are without treatment.
The diagnosis is clinical and begins from the patient’s own complaint or a nearby family member, who observes recurring episodes of forgetfulness and memory difficulties. From there, specific tests should be performed to evaluate cognitive functions and the degree of impairment of autonomy in daily activities.
Also according to the report, about 8.5% of the Brazilian population aged 60 and older have some kind of dementia – which represents about 2.71 million cases. With the progressive aging of the population, the perspective becomes more alarming: it is estimated that the number of dementia cases in the country almost triply by 2050. Given this scenario, the search for alternatives that offer more substantial and accessible benefits to patients is increasingly necessary.
How Donanemabe Acts
Alzheimer’s manifests by a progressive deterioration of memory, language, behavior and the ability to perform everyday tasks. The condition is associated with the abnormal accumulation of two proteins in the brain: tau and beta-amyloid, which cause the death of neurons and lead to the advancement of the neurodegenerative picture over the years.
Anvisa’s newly approved monoclonal antibody acts directly on the removal of beta-amyloid plates in the brain. “Unlike acetylcholinesterase inhibitors such as donepezila, rivastigmine and galantine, which increase the availability of acetylcholine, a fundamental neurotransmitter for memory, cognition and learning, Donanemabe is considered an advance in the root of the problem, rather than just relieving cognitive symptoms,” explains neurologist Polyana Piza, manager of the program, manager Neurology of Israeli Hospital Albert Einstein.
Developed by pharmacist Eli Lilly, based in the United States, Donanemab will be marketed under the name of Kisunla. Studies have shown that with 76 weeks of use, it can reduce Alzheimer’s progression by up to 35% in patients in the early stages of the disease.
Potential risks
Despite promising results, Donanemabe may have its use limited by bringing few benefits to individuals with moderate or severe paintings. Studies show that the removal of amyloid plates is not enough to reverse the established dementia.
In addition, although they are rare, the drug has some risks, especially increased Aria rates (amyloid -related image abnormalities), side effect associated with small bleeding and swelling areas in the brain and even death. In rehearsals with the drug, 1.6% of participants who received Donanemabe presented serious Aria events, with three deaths.
More severe cases of Alzheimer’s tend to be more frequent in people who carry the Apolipoprotein and ε4 (APOE ε4) gene. Located on chromosome 19, this gene is considered an important genetic risk biomarker for the condition. Currently, it is possible to perform the genetic test of APOE ε4 only in private laboratories.
Studies show that people without copies of the APOE ε4 gene have a significantly lower risk of serious side effects when using medication, with a rate of only 0.8% and a single fatality record. Precisely for this reason, for a patient to be considered eligible for treatment with this type of drug, it is necessary to undergo a careful evaluation.
This screening includes genetic tests to identify the presence of APOE ε4, as well as image exams, such as the amyloid pet, which confirm protein accumulation in the brain. “The risk of small brain bleeding also makes the drug contraindicated for those who use anticoagulants, which is very common in the elderly and can further limit the eligibility for Donanemabe,” says Piza.
It was exactly this risk of serious adverse effects, such as brain bleeding and deaths, which led the European Medicines Agency (EMA) drugs for human use (CHMP) to issue a negative about the authorization of Donanemab in Europe.
In its report, the agency acknowledged that the drug is effective in removing beta-amyloid plates, but assessed that the clinical benefits obtained so far are modest. Given this, it concluded that the potential health risks of patients exceed the therapeutic advantages offered, making their approval in European territory impossible.
The Alzheimer Europe Association regretted the negative opinion. In NOTE PUBLISHED ON YOUR SITEIt mentions that the drug was approved by other regulatory authorities around the world, including the US Food and Drug Administration (FDA) and others in the United Kingdom, Japan and China (at the time, Anvisa had not yet approved the drug in Brazil).
High cost
Another point is that the high cost of the drug may limit drug access and make it difficult to viability on a large scale. Donanemabe has not yet been priced in Brazil, so it is not available either in the private network or by the Unified Health System (SUS).
Sought by the agency Einstein, Eli Lilly reported that there is no price estimate in the country, but “will work to ensure product availability as soon as possible.” At the moment, the company says, the priority is a definition of price by the Market Regulation Chamber (CMED), linked to Anvisa.
In the evaluation of Polyana Piza, Donanemabe represents an important innovation in the treatment of Alzheimer’s disease, offering a new therapeutic option, although clinical improvement is still modest. “The approval of this medicine can encourage the search for early diagnoses, as it is more effective at early stages of the disease, which is crucial to maximizing benefits and slowing the progression of the disease,” says Einstein neurologist.
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This content was originally published in see the pros and cons of the new drug to treat Alzheimer’s on the CNN Brazil website.
Source: CNN Brasil
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