The FDA has approved the marketing of the drug developed by Eisai and Biogen
The drug agency USA, the FDA in its acronym in English, has given the green light this Friday to the commercialization of lecanemabthe drug than the Japanese pharmacist Eisai has been investigating together with the American Biogen and that it reduces the worsening of Alzheimer’s symptoms by up to 27% after being administered for 18 months. The medicine will be sold under the name of leqembi.
Last November, the scientists confirmed the efficacy of lecanemab, although they also urged further investigation of the possible side effects of the treatment. The Pasqual Maragall Foundation, a benchmark in Alzheimer’s research and treatment, applauded the results of this work at the time. “It is only the beginning because the changes are modest and you have to do clinical trials longer. But it is a very important step forward,” the entity’s director, Arcadi Navarro, pointed out to EL PERIÓDICO.
Lecanemab, whose results are “clinically relevant,” is the “first drug that truly modifies the course of the disease.” This is truly its importance. “There were already medications to treat the symptoms, but this really slows down cognitive decline,” Navarro stressed.
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Also the Spanish Confederation of Alzheimer’s (Ceafa) awaited the arrival of the new drug with “optimism”. “However, experience makes us cautious after the aducanumab failure. The results reveal an effectiveness of 27%, which is infinitely higher than what we currently have, so at Ceafa we believe that the way is to continue investigating. Continue investigating on the one hand to have an early diagnosis, since these drugs, the sooner they are administered, the better; and on the other hand, to continue researching this type of medication so that this percentage of effectiveness increases,” the entity argued.
The drug approved in the US, however, is not without controversy due to the risks of causing cerebral hemorrhages and because one person died in clinical trials. The cost announced by Eisai is 26,500 dollars (about 25,000 euros) per year, a little more than half of what was initially planned, which was 56,000 dollars.