In early June, an expert advisory committee recommended marketing authorization for Kisunla, whose scientific name is donanemab, which is administered by intravenous injection. It attacks so-called amyloid plaques found in the brains of Alzheimer’s patients. These plaques are deposited between nerve cells in the cerebral cortex and disrupt the connections between neurons.
Donanemab belongs to a new class of Alzheimer’s treatments based on immunotherapy, a process that directly mobilizes immune cells to act on these plaques.
Cognitive decline slowed
In clinical trials, donanemab slowed the progression of this degenerative disease, while causing serious side effects in some patients, including brain hemorrhages.
“Clinical data convincingly showed that Kisunla reduced the rate of cognitive and functional decline in patients with moderate symptoms of cognitive loss and senile dementia related to Alzheimer’s disease,” said Teresa Buracchio, director of the FDA’s Office of Neuroscience, in the statement released Tuesday.
The agency had already approved, in July 2023, another treatment working on the same principle, marketed under the name Leqembi (lecanemab molecule) and developed by the Esai and Biogen laboratories.
Aduhelm, the first Alzheimer’s treatment approved since 2003, has already been withdrawn
Eli Lilly is currently conducting clinical trials of another treatment aimed at slowing the progression of Alzheimer’s disease, remternetug, which has shown positive initial results.
In 2021, the first treatment of this new generation, Biogen’s Aduhelm (aducanumab molecule), was authorized, at the end of a highly criticized accelerated procedure, before being withdrawn from the market in early 2024. Its price, $56,000 per year, had caused controversy, with the American health insurance for people aged 65 and over, Medicare, refusing to reimburse it, on the grounds that, in addition to the cost, its long-term effectiveness had not been established. Aduhelm was the first treatment for Alzheimer’s disease approved in the United States since 2003.
Eli Lilly shares fell 0.84% on Tuesday, suffering the effects of their recent rally. The stock has gained nearly 58% since the start of the year.
