The Food and Drug Administration (FDA) in the United States has given the green light to the marketing of a new treatment against Alzheimer’s, which slows the progression of the disease, developed by the American laboratory Eli Lilly.
New discoveries in the diagnosis of Alzheimer’s disease PHOTO Shutterstock
An advisory committee of experts had recommended, at the beginning of June, the authorization for the marketing of the drug Kisunla (donanemab), which is administered by intravenous injection, according to Agerpres.
The drug attacks so-called amyloid plaques, which are found in the brains of Alzheimer’s patients. These plaques are deposited between nerve cells in the cerebral cortex and interrupt the connections between neurons.
Donanemab is part of a new class of treatments for Alzheimer’s disease based on immunotherapy, a process that directly mobilizes immune cells to act on these plaques.
In clinical trials, donanemab slowed the progression of this degenerative disease, although it caused serious side effects in some patients, especially cerebral hemorrhages, AFP notes.
“Clinical data convincingly demonstrated that Kisunla reduced the rate of cognitive and functional decline in patients with moderate symptoms of cognitive loss and senile dementia associated with Alzheimer’s disease,” commented Teresa Buracchio, director of the Office of Neurosciences within the FDA, quoted in a press release published on Tuesday.
The agency had already approved, in July 2023, another treatment, which works on the same principle, marketed under the name Leqembi (lecanemab), developed by Esai and Biogen laboratories.
Eli Lilly is currently conducting clinical trials on another treatment aimed at slowing the progression of Alzheimer’s disease, remternetug, with positive preliminary results.
In 2021, the first treatment of this new generation, Biogen’s Aduhelm (aducanumab) was approved after a heavily criticized fast-track procedure, before being withdrawn from the market in early 2024.
Its price of $56,000 a year has caused controversy, with the US health insurance system for people over 65, Medicare, refusing to cover it, on the grounds that its long-term effectiveness has not been well established.
Aduhelm was the first Alzheimer’s treatment approved in the United States after 2003.