2023-05-04 08:48:02
The American pharmaceutical group Eli Lilly has announced that it has obtained very promising results during a large-scale clinical trial.
The American pharmaceutical group Eli Lilly said on Wednesday that its new treatment developed against Alzheimer’s had been shown, during a large clinical trial, to slow the progression of the disease, an announcement which paves the way for its possible authorization soon.
These results were greeted with enthusiasm by the experts, who did not hesitate to welcome the entry into a “new era” for the management of Alzheimer’s disease, thanks to several recent breakthroughs.
The clinical trial, which had 1,200 participants between the ages of 60 and 85 and who had not yet reached an advanced stage of the disease, showed a 36% reduction in cognitive decline in patients treated with donanemab, according to a press release. of the company.
The ability to perform everyday tasks, such as driving, conversing, having hobbies or managing finances, was also measured. Over 18 months, participants who received the treatment showed a 40% reduction in decline in their ability to perform these tasks.
Eli Lilly said he plans to file for FDA approval this quarter, and globally “as quickly as possible”.
However, the treatment can lead to serious side effects, such as edema or cerebral hemorrhage. Three participants in the clinical trial have died, according to the statement.
“When the full results will be published” in a scientific journal “we can begin to carefully weigh the risks and benefits, and that will help decide whether donanemab should be given routinely to patients”commented Dr. Charles Marshall, of Queen Mary University of London.
New treatments
Research in the fight against Alzheimer’s disease has stagnated for decades.
But two new treatments, developed by the Japanese pharmaceutical companies Eisai and the American Biogen, have recently been approved in the United States: Leqembi in January 2023 (whose active ingredient is called lecanemab), and before that Aduhelm (molecule aducanumab), in June 2021.
While the authorization of Aduhelm was controversial, with many experts criticizing the lack of evidence on its effectiveness, lecanemab was the first to clearly demonstrate a reduction in cognitive decline (by 27%) in a trial clinical.
Limited access
Access to these treatments, which are administered intravenously and are very expensive, is arousing debate in the United States.
The federal Medicare health coverage system, intended for people over 65, had announced that it would reimburse them only if they were taken in the context of clinical trials – de facto greatly limiting their access.
This condition was imposed because the FDA authorized Aduhelm and Leqembi according to an accelerated procedure, which requires the collection of less clinical data in order to allow the faster marketing of a treatment against a serious pathology.
Eli Lilly indicated on Wednesday that it wanted to file an application for authorization “traditional” (not expedited), which could allow for broader Medicare coverage.
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