An advisory committee of American experts recommended on Monday the authorization of a new treatment for Alzheimer’s developed by the pharmaceutical group Eli Lilly, paving the way for a favorable decision by health authorities.
Eleven independent experts, convened at the request of the US Food and Drug Administration (FDA) to review the clinical trial data, unanimously found donanemab to be effective in patients at an early stage of the disease.
They also considered, in a second vote, that the benefits of the treatment outweighed its risks.
One of the experts, Sarah Dolan, considered that there is an “immense” need for new treatments, although patients and doctors will need to receive “a lot of information” about Eli Lilly’s disease to ensure good follow-up.
Treatment administered intravenously.
Several experts, however, lamented the lack of data on certain populations within the clinical trial, particularly among African Americans.
The FDA is not required to follow the committee’s advice, but it is rare for it not to.
The drug belongs to a new class of Alzheimer’s treatments that currently center the hopes of patients and their families. Donanemab is administered intravenously and attacks plaques in the brains of Alzheimer’s patients, called amyloid plaques.
In a clinical trial, donanemab was shown to slow the progression of this degenerative disease, while causing serious side effects in some patients, such as brain hemorrhages.
The FDA delayed the treatment’s expected authorization in the spring to more closely examine the data and convene this expert committee. Eli Lilly shares ended the day higher on the New York Stock Exchange on Monday.
A first treatment of this kind withdrawn from the market.
Last year, the FDA approved another treatment that acts in a similar way, marketed under the name Leqembi (lecanemab molecule) and developed by Eisai and Biogen.
The FDA’s decisions regarding Alzheimer’s have been the subject of special attention since the controversy surrounding a first treatment of this class, Aduhelm from the American company Biogen, whose authorization in 2021 under an accelerated procedure had been highly criticized. The Aduhelm has since been removed from the market.
Research in the fight against Alzheimer’s was stagnant for decades and Aduhelm was the first approved treatment against the disease since 2003.
Source: BFM TV
