2023-05-04 10:02:36
The American pharmaceutical group Eli Lilly declared on Wednesday that its new treatment once morest Alzheimer’s had proved its worth. In a large clinical trial, the drug slowed disease progression. These results were enthusiastically received by the experts.
The clinical trial had 1,200 participants aged 60 to 85 who had not yet reached an advanced stage of the disease. Donanemab treatment showed a 36% reduction in cognitive decline in patients. Daily autonomy (driving, conversing, having hobbies, managing finances) was also measured: over 18 months, patients showed a 40% decline in their ability to perform these tasks.
Risks still to be assessed
Eli Lilly 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 group’s statement.
“When the full results are released, […] we can start to carefully assess the risks and benefits,” said British doctor Charles Marshall. “This will help decide if donanemab should be routinely given to patients. »
Soon a treatment choice for patients
“These results confirm that we are entering the era of Alzheimer’s treatment,” said Catherine Mummery, a London researcher. ” [On peut désormais] realistic expectation of being able to treat and stabilize a person with Alzheimer’s disease, with long-term management, rather than palliative and supportive care. »
After years of stagnation in the fight once morest Alzheimer’s disease, new results indeed give hope. Two new treatments, developed by the pharmaceutical companies Eisai (Japan) and Biogen (United States), have recently been approved in the United States: Aduhelm in June 2021 and Leqembi in January 2023.
Eli Lilly’s donanemab, if approved, might thus offer patients a treatment choice. All of these drugs target amyloid beta protein deposits. 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.
The question of reimbursement in the United States
Access to these very expensive treatments has sparked debate in the United States. The Medicare health coverage system, intended for those over 65, had announced that it would reimburse them only within the framework of clinical trials. A condition imposed because the FDA authorized Aduhelm and Leqembi according to an accelerated procedure, which requires collecting less clinical data before marketing.
“Medicare continues to stubbornly block access for people who might benefit from it,” criticized Maria Carrillo, scientific manager at the Alzheimer’s Association, on Wednesday, who is calling for these access restrictions to be lifted. For its part, Eli Lilly will file a request for “traditional” authorization in order to allow broader coverage by Medicare.
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