Alzheimer’s | Authorization for treatment postponed for more analyzes

(Washington) The expected authorization of a treatment against Alzheimer’s disease developed by Eli Lilly will ultimately take longer than expected, the pharmaceutical giant announced on Friday, with the American Medicines Agency (FDA) wishing to achieve 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.

In a clinical trial, donanemab was shown to slow the progression of this degenerative disease, which affected approximately 6.7 million Americans aged 65 and over in 2023, according to health authorities.

But it also caused serious side effects in some patients.

The FDA’s decision is a “hard blow” for Eli Lilly, reacted Robert Howard, professor of psychogeriatrics at University College London (UCL).

For Anne White, the group’s executive vice-president quoted in the press release, “it was unexpected to learn that the FDA was going to convene an advisory committee at this stage of the evaluation process.”

But we “look forward to the opportunity to further present” the results of the clinical trial, she added.

” A suprise ”

The FDA also wants to look into the drug administration protocol, according to Eli Lilly.

This decision by the American agency is “a surprise”, the Alzheimer’s Association also reacted in a press release. But “safety and appropriate administration of the treatment are essential,” she said, calling on the FDA to act “quickly” for “all those who could benefit from this treatment.”

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.

It 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.

Donanemab had been shown to slow the progression of the disease, especially when taken early in its course.

But the treatment can also cause serious side effects, such as edema or cerebral hemorrhages. Three deaths of clinical trial participants are likely linked to the treatment, according to the study.

Last year, the FDA approved a first treatment acting in a similar way against Alzheimer’s, marketed under the name Leqembi (lecanemab molecule), and developed by Eisai and Biogen.

But side effects such as edema or brain hemorrhages “are twice as common with Eli Lilly’s donanemab” as with Esai’s lecanemab drug, Professor Robert Howard said.

It is therefore a question of assessing whether the risks incurred are not too great in relation to the benefits provided by this new treatment.

The FDA’s decisions on the subject of Alzheimer’s have been particularly scrutinized since the controversy surrounding a first treatment of this class, Aduhelm from the American company Biogen, whose authorization under an accelerated procedure by the American agency had been widely criticized. The Aduhelm has since been removed from the market.


Leave a Comment