The health authorities in the United States and Europe have once again collided with medications that should reach patients that are not. The difference, … At the present time, he has nothing to do with the controversial minister of health that Trump, Robert Kennedy Junior, is anti -hostile to the two clubs, when he aspired to the presidency chose Vice President Aaron Rodgers, an American legend who refused to feed against Kovid and usually participated in Aymanaska. The confrontation comes before, and it has now been manifested again with the latest commercial treatment against Alzheimer’s. Specifically, through a drug called Donaneemab, which was approved on the other side of the Atlantic Ocean in July last year and the European Pharmaceutical Agency (EMA) rejected.
The European Pharmaceutical Agency recommended denying the marketing license in Kisunla -the name of Donaneemab commercial. In contrast to the American authorities, the company says that the Europeans consider that the risk of risk exceeds its benefits. In this case, the risk is called the company: registered.
“The FDA and EMA analyzes the risks and interest. Both are provided with similar data. Noura Benjoa, Eckerbas researcher at the Center for Neuroscience, says at least in the field of neurological degenerative diseases, in the United States faster. “In Europe we are more conservative in this regard. It is also expensive drugs and in Europe is generally funded. Maria Joseva Garcia Pragado, a professor of pharmacology at the University of Salamanca, confirms if the benefits are not clear, she has not been approved.
Monoism antibodies
Basically, treatments against Alzheimer’s are divided by those who try to preserve healthy brain cells that have not yet been affected by the disease and those that seek to eliminate the accumulation of proteins-in the form of Ovillus, and Beta-Ayloid, in the form of panels, a perceived cause. Among the first, one of the most common things is Alzrta, which is dedicated to delaying memory loss. Donaneemab is part of the seconds. It is a laboratory protein-called unilateral antibodies-installed in beta-amyed panels so that the body’s defenses can eliminate them.
What happened with this medicine remembers what happened with controversial upucanumab, the pioneer of this family of drugs. It admitted by the FDA in 2021, it was a revolution because it was the first treatment that was approved in two decades. However, Europe opposed. Doubts were never clear about their real effectiveness and cost cost at $ 40,000. Biogen, the pharmacist who created it, decided to withdraw it “to give priority to its resources from Alzheimer’s disease.”
At the end of last year, the issue arose again with Lecanemab, an other monochromatic body created by the same Biogen. The United States agreed to this in January 2023, while Europe rejected it. EMA will finally give its arm – with restrictions – in November last year due to the pressure of many experts and patients, who saw how they could not reach the only treatment that showed some event against the progress of the disease when it was at its first stadium.
What is the difference between the two? “In fact, the attacking panels are in reality, and the paintings are a group of waste among them and many other proteins, fats, and membrane fragments …-but Likanimab has smaller targets,” explains the expert in Basque. It also diverges in their safety. The data shows that the risk of Aria with Donaneemab practically bends from its predecessor. “It was a surprise. “There was a hadith that he would be safer,” says Ruiz.
“They both slow down, do not stop, cognitive deterioration. “If they can stop it, there will be more reasons for taking risks,” Bingo is saved. It is estimated that 57 million people suffer from the most common neurological degenerative diseases, which is expected to double three times in 2050.
A shot and only for 10 % of patients
When approaching the approval of these recent drugs, the costs are considered a factor. The treatment annually reaches about 40,000 euros, which must be added to “change the brutal logistics.” “It takes a very intense selection process, as well as a high -end follow -up with the echo of the brain,” says Javier Ruiz.