It is not a miracle cure, and the FDA, the American drug agency, does not intend to believe it. By authorizing, this Friday, January 6, the large-scale use of Leqembi, a drug jointly developed by the Japanese laboratories Esai and American Biogen, it nevertheless hopes to slow down the cognitive deterioration of patients recently affected by Alzheimer’s disease. , which affects 6.5 million Americans.
Clinical trials show that the development of this drug is “an important step forward in the fight against Alzheimer’s disease”, in the words of the federal agency. In fact, 18 months of studies carried out on nearly 18,000 people showed a decrease in cognitive decline of 27% in treated patients.
Leqembi is based on an active ingredient called lecanemab, whose action reduces the amyloid plaques that develop around the neurons of sick people and end up destroying them. This treatment is more promising than others, and in particular a certain aduhelm, yet authorized by this same FDA in June 2021. Many scientists, and even FDA officials, then expressed their concern about the lack evidence on the real effectiveness of this drug. The price of the aduhelm, $56,000 a year, had also shocked Congress, which recently made this known in a report. Because it is still on sale, but reserved for people newly affected.
Precautions but uncertainties
So this time, the US health authorities specified that the potential adverse effects of Leqembi would be listed on its label, including the risk of brain swelling and internal bleeding, which claimed the lives of three people during the 18 months of test. Two of them were taking coagulants, which led specialists to advise against this combination. Also, Leqembi is reserved for people who have not yet reached an advanced stage of the disease, which brings the number of people likely to receive it to around 100,000.
Finally, the price of the treatment, capped at 26,500 dollars, is out of all proportion to the adulhem. Despite the encouraging results and the precautions mentioned, many scientists want to be cautious. In le New York TimesDr. Thambisetty, an Alzheimer’s disease specialist, warns that “from the point of view of a doctor caring for patients with Alzheimer’s disease, the difference between lecanemab and placebo is well below of what is considered a clinically significant therapeutic effect”.