(Washington) The expected authorization of a treatment against Alzheimer’s disease developed by Eli Lilly will be delayed, the pharmaceutical giant announced on Friday, the American Medicines Agency (FDA) wishing to carry out more analyzes.
The FDA “has informed” Eli Lilly “that it wants to better understand matters related to the evaluation of the safety and effectiveness of donanemab,” the American company said in a statement.
A meeting of experts must therefore be convened, “the date of which has not yet been set by the FDA, and as a result, the timetable for expected action from the FDA on donanemab will be delayed beyond the first quarter 2024,” adds the press release.
The drug belongs to a new class of treatments against Alzheimer’s, another of which has already been authorized, which are currently focusing the hopes of patients and their families.
This degenerative disease affected approximately 6.7 million Americans aged 65 and over in 2023, according to health authorities.
“It was unexpected to learn that the FDA was going to convene an advisory committee at this stage of the evaluation process,” said Anne White, executive vice president of the group, quoted in the press release. But we “look forward to the opportunity to further present” the results of the clinical trial that evaluated the drug.
Donanemab is given intravenously and attacks plaques in the brains of Alzheimer’s patients, called amyloid plaques.
The results of a large-scale clinical trial were published this summer in a scientific journal.
The clinical trial for Eli Lilly’s treatment was conducted in eight countries on more than 1,700 people aged 60 to 85, who had not yet reached an advanced stage of the disease.
This clinical trial had shown to slow the progression of the disease in patients, especially when taken at the very beginning of the disease.
But the treatment can also cause serious side effects, such as edema or cerebral hemorrhages. Three deaths of clinical trial participants are likely related to the treatment, according to the study.
Last year, the FDA approved a first similar treatment for Alzheimer’s, Leqembi (lecanemab molecule), developed by Eisai and Biogen.