In what was for many a message of encouragement in research against the disease -a very fruitless fight, the US authorities authorized this Monday a drug against Alzheimer’s, an approval that generated severe questions from the scientific community, because many interpreted this authorization as a drug that cures disease. Review the keys to this authorization and its subsequent controversy.
1. What happened?
It is a fact that had not occurred since 2003. And before, authorized treatments only responded to the symptoms of Alzheimer’s, but not to the causes of this disease.
Biogen treatment seeks to destroy the plaques formed by certain proteins, called “amyloids”, in the brain of the sick. These deposits compress neurons and are one of the main factors in Alzheimer’s disease, leading to irreparable memory loss.
2. Is it a turning point?
It is “a turning point in the research of new revolutionary treatments against Alzheimer’s disease”, estimated in a statement Hilary Evans, director of the British foundation Alzheimer’s Research.
The sick and their families have at last a specific announcement after almost two decades without new advances in treatment.
“It is a period during which much progress has been made in understanding the disease – how it is declared, why it is declared – and about its diagnosis,” especially in its early stage, he told the AFP agency Stephane Epelbaum, neurologist and researcher at the hospital Pitié Salpêtrière de París. “But all these advances are difficult to transfer into therapeutic advances.”
Meanwhile, the disease is gaining ground, as a consequence of the aging of the population. The World Health Organization (WHO) speaks of at least thirty million cases in the world, although it is often difficult to differentiate Alzheimer’s from other dementias.
3. Is it possible to cure Alzheimer’s now?
No, the cure for this ailment is not yet possible. “I’m afraid there is inordinate hope for the efficacy of the treatment” from Biogen, Epelbaum warns.
The drug, with a very high price (more than $ 50,000 per year), It is only intended for a small part of the sick, in a very early stage of the disease. And even in them, the effectiveness is limited.
Alzheimer’s does not progress very quickly, and in the 18 months during which the Biogen treatment was tried, cognitive tests showed only a small difference between patients who took it and those who received a placebo.
The pharmaceutical group also caused confusion when it announced in 2019 the failure of one of its trials, although then he backtracked on his statements.
An expert committee advised the FDA to reject the treatment. In the European Union and the United Kingdom, where Biogen also requested authorization, it appears that the process will be slower.
Should the United States have waited? Not necessarily, because your decision will allow you to evaluate the effectiveness of the treatment in the real world.
4. What about the other investigations?
Other investigations carried out by large groups continue, although some pharmaceutical companies, such as the American Pfizer in 2018, they gave up advancing in that field.
“For industrialists who are investigating this disease, (the FDA’s decision) continues to be a positive message because otherwise there is a real risk of simply abandoning the investigations,” Epelbaum considers.
Several American Labs Announced Encouraging Results This Year, What Eli Lilly which also seeks to destroy amyloid plaques, the main clue in studies in recent decades.
Other companies follow different strategies but also get positive data. Annovis, for example, focuses on proteins called Tau, also related to Alzheimer’s. And Cassava tries to prevent the formation of amyloid plaques, instead of destroying them.
But in these three cases, the results are limited because the investigations were carried out in few patients.
“No drug – no matter how good – will not be the only solution to Alzheimer’s,” the neurologist concluded on Twitter on Wednesday. Jonathan Schott, of the University College de London, insisting on the prevention of these dementias.
Check out our podcast with the vision of Nibaldo Inestrosa, National Prize of Natural Sciences 2008 for his Alzheimer’s research and director of the Center for Aging and Regeneration of the Catholic University (Care UC).