Hopeful Yet Cautious: São Paulo University on New Alzheimer’s Drug
Drug that slows the progression of Alzheimer’s is effective, according to a panel from the FDA, the federal health agency of the United States. The consultants of the North American agency voted unanimously in favor of the effectiveness of Donanemab, which slows the progression of the disease by 60% in the initial stages. The committee considered that the benefits outweigh the risks, paving the way for the final decision of the United States agency. Professor Orestes Forlenza, from the Department of Psychiatry of the School of Medicine of USP, considers the drug to be a “light at the end of the tunnel” for the treatment of Alzheimer’s – a disease that has been a great challenge for researchers and for which there is still no cure. On the other hand, Forlenza has a series of reservations about the drug, such as cost, side effects and modest benefits.
Donanemab is one of the drugs that make up a new class of medications that aim to slow or even prevent the progression of the pathological process of Alzheimer’s disease. It is a drug that has been under study for several years, so much so that the results were only recently published. The proposal of this new class, according to the USP physician, “is the formulation of monoclonal antibodies, which are antibodies ready to remove beta amyloid (a peptide that is attributed to the origin of Alzheimer’s)”. He adds: “Obviously, administering these antibodies is complicated. It has to be done via infusion and the studies are quite complex”. It is important to emphasize that the first drugs tested in this class failed; there are several drugs with a very similar proposal, but they were discontinued.
Donanemab is therefore the most recent drug and, for now, the most promising. As the professor commented, the purpose of the drug is to remove the amyloid peptide, which “is an abnormal cleavage of a neuronal protein, exerting a toxic effect and a cascade of events that lead to neurodegeneration,” he explains. Removing the amyloid from the brain would result in an attenuation of the symptoms of the disease.
Counterpoints
Although the results of the research are the most promising currently, “the results were not as good as expected. The clinical benefit is small, although the amyloid is removed,” says Forlenza. He says that there is practically a consensus in the scientific community that the peptide is the cause of Alzheimer’s, so the expectation was that the effects of the drug would be better.
He also emphasizes that Donanemab is only indicated in very early cases of the disease. “This drug will not be useful for all patients, because the clinical benefit is tied to a very specific moment in the progression of this disease and it is almost certain that there will be no benefit, if the condition has already set in, it is too late”, says Forlenza. The benefits would be restricted only throughout the course of the disease.
For this reason, he says it is absolutely vital that the drug be prescribed under strict criteria, because if it does not meet these criteria, the positive effect will not occur, with the risk of negative side effects. Furthermore, the drug cannot be spent in any way: its use costs US$60,000 per year, approximately R$320,000. With this in mind, he comments that Donanemab, if approved, will be restricted to a small group of people.