Alzheimer, over 50 million worldwide suffer from the disease
Over 50 million people worldwide are affected by Alzheimer’s. Since German physician Alois Alzheimer discovered the disease over a century ago, no one has yet found either the cure or even the reasons why it develops. The research, however, between failures and small steps forward, continues and it is news these days that could illuminate the path to a cure-all drug. In fact, the expert committee of the Food and Drug Administration (FDA) has given a positive opinion on the implementation of the Lecanemab. A drug that is certainly not a cure but that delays the cognitive decline caused by the disease by 27%. The Nervous System Medications Advisory Committee, made up of six independent specialists, analyzed the results of the Clarity clinical trial on the drug’s efficacy and gave the ok. It is known that the opinion of the super experts is always preparatory for the final decision of the FDA. The drug opens hopes. Although the effects are modest, Lecanemab is the first in decades that has shown positive effects on slowing down the disease.
Alzheimer, the FDA’s decision for the drug, useful for patients with early Alzheimer’s, will soon be released
Now the decision is up to the FDA which will have to give the definitive green light to the drug (now only temporarily free) especially useful for patients with early Alzheimer’s. A next step after the American yes will be that of the European Medicines Agency which will have to approve it at the beginning of next year, but whose yes is by no means a given. But on a scientific level, what is the new drug and how does it work? Lecanemab, marketed as Leqembi, is a monoclonal antibody. It is injected into a vein to target the amyloid protein plaques in the brain (a marker of the disease) and help them to be removed. The Clarity study looked at 900 people (ages 50 to 90) with early symptoms of Alzheimer’s. The drug was able to slow the progression by 27%. In practice, in patients who had taken the drug the progression of the disease was delayed by six months compared to those who had not taken it. It will be necessary to understand whether the effects will last beyond the 18-month trial period.
Alzheimer, many critical side effects of the new drug
So all good? Far from it because if it is also true that these modest results are the first ever for decades of research, there are many critical issues. In fact, the side effects are neither few nor insignificant. Brain hemorrhages and brain swelling. Unfortunately, three patients with brain hemorrhages died during clinical trials, probably due to the drug and its interaction with anticoagulants. Studies have in fact found that the problems arise more in patients taking anticoagulants. Additionally, Lecanemab is critical for people with the E4 mutation in the APOE gene. Precisely these people are the ones who need the drug the most, given that this mutation multiplies the risk of contracting Alzheimer’s by five. Another problem that appeared in another study is that Lecanemab seems to shrink the brain of patients. Although it is not clear whether this process could create problems for the health of patients. Many scientific opinions agree that the drug could delay the onset of more serious stages of the disease for nearly three years. Another of the important questions that need to be answered is how much it will cost the Leqembi. Monoclonal antibodies are among the most expensive drugs in the world. Aducanumab, a lecanemab-like antibody being developed by Biogen against Alzheimer’s, costs $56,000 per patient. But that could change with Lecanemab and other similar drugs. In May, the pharmaceutical company Lilly announced that donanemab, another monoclonal antibody against the amyloid protein, slowed cognitive decline by 35%. Their findings suggested that the drug could delay the onset of more severe stages of the disease for almost three years. Alzheimer’s presents a huge challenge because it begins to develop decades before the first symptoms appear. What to do to bring this drug to patients safely. Many experts agree that approval associated with specific guidelines and protocols, with meticulous monitoring and prioritization of ideal candidates, would be reasonable. In Europe, for example, with national health systems, it would be necessary to develop a strategy in advance for its application and avoid the collapse of neurological assistance services.
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