Promising results for a new Alzheimer's treatment

UPDATE DAY

The American pharmaceutical group Eli Lilly said on Wednesday that its new treatment developed against Alzheimer's had been shown in a large clinical trial to slow the progression of the disease, an announcement which paves the way for its possible authorization next.

These results were enthusiastically received by the experts, who did not hesitate to hail the entry into a “new era” for the management of Alzheimer's disease, thanks to several recent breakthroughs.

The clinical trial, which included 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 company statement.

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 apply for clearance from the Agency (FDA) from 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 clinical trial participants have died, the statement said.

“When the full results are published” in a scientific journal, “we can begin to carefully weigh the risks and benefits, and that will help to decide whether donanemab should be routinely given to patients,” commented Dr. Charles Marshall, 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. /p>

“I believe this treatment has the potential to significantly improve the lives of patients and their families,” echoed 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 clinical trial.

Eli Lilly's donanemab, if “approved alongside lecanemab,” could “offer treatment options for patients,” said University of Bristol professor Liz Coulthard.

< p>All of these new treatments target the deposits of a protein called beta-amyloid. While the exact cause of Alzheimer's disease remains poorly understood, patients' brains exhibit amyloid plaques, which form around their neurons and eventually destroy them.

Access to these treatments, administered by intravenous and very expensive, has sparked debate in the United States.

The federal health insurance system Medicare, intended for people over 65, had announced that they would reimburse only if taken in clinical trials—de facto greatly limiting their access.

This condition was imposed because the FDA cleared Aduhelm and Leqembi under a fast-track process , which requires the collection of less clinical data in order to bring a treatment for a serious illness to market more quickly.

“Medicare continues to stubbornly block access for people who could benefit from it”, criticized Maria Carrillo, scientific officer at the Alzheimer Association, in a press release on Wednesday, who is calling for these access restrictions to be lifted.

Eli Lilly indicated on Wednesday that he wanted to file a request for “traditional” (not expedited) authorization, which may allow for broader Medicare coverage.