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 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 from 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 an application for authorization with the American Medicines Agency (FDA) this quarter, and in the world “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 are 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.
Alzheimer’s disease is a neurodegenerative disease that affects tens of millions of people worldwide, and for which there is no treatment allowing a complete cure. First characterized by memory loss, patients gradually lose the ability to live normally.
“These results confirm that we are entering the era of Alzheimer’s treatment,” said Catherine Mummery, from the National Hospital for Neurology and Neurosurgery in London. It will now be possible “to realistically hope to be able to treat and stabilize a person with Alzheimer’s disease, with long-term management, rather than palliative and supportive care”, she added.
“I believe this treatment has the potential to significantly improve the lives of patients and their families,” said Dr Marc Busche, of University College London (UCL).
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.
Eli Lilly’s donanemab, if “approved alongside lecanemab,” could “offer a choice of treatments for patients,” said Liz Coulthard, a professor at the University of Bristol.
All of these new treatments target deposits of a protein called beta-amyloid. While the exact cause of Alzheimer’s disease remains poorly understood, patients’ brains show amyloid plaques, which form around their neurons and eventually destroy them.
Access to these treatments, administered intravenously and 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.
“Medicare continues to stubbornly block access for people who could benefit from it,” criticized Maria Carrillo, scientific officer at the Alzheimer’s Association, in a statement on Wednesday, calling for these access restrictions to be lifted. .
Eli Lilly said Wednesday he wants to file for “traditional” (not expedited) authorization, which could allow for broader Medicare coverage.