The new Alzheimer's drug from Eli Lilly may receive the American license this year

It is expected that a drug for Alzheimer's developed by the American pharmaceutical company "Eli Lilly" will be licensed in the United States this year, after the full results of a large-scale clinical trial were published on Monday.

The results confirmed the effectiveness of the drug donanemab in slowing down the progression of symptoms in patients, especially if they begin using it in the early stages.

However, some experts expressed caution about this drug, considering its benefits to be "modest" and that it causes serious side effects.

Last May, the U.S. Food and Drug Administration (FDA) approved a similar drug for Alzheimer's called "lecanemab" (Leqembi), produced by the Japanese pharmaceutical group "Eisai" in collaboration with the American company "Biogen," with lecanemab being its active ingredient.

Eli Lilly reported that it expects a decision from U.S. health authorities "by the end of this year," and it is also preparing to submit license applications for the drug in other countries.

Like lecanemab, donanemab is administered intravenously and works by targeting and eliminating proteins in the brains of patients called "amyloid."

The clinical trial for Eli Lilly's drug was conducted in eight countries on more than 1,700 people aged between 60 and 85 who had not yet reached an advanced stage of the disease. The results were published on Monday in the scientific journal "JAMA."

For a subgroup of 1,200 people with low levels of a protein called tau, which indicates an early stage of the disease, the drug contributed to a 35% reduction in cognitive and functional decline (the ability to perform daily activities) over 18 months.

However, the study warned that the drug could lead to serious side effects, including brain swelling or bleeding. The drug is also suspected to have caused the deaths of three of the trial participants.

In a commentary article also published in "JAMA," some experts stated that "patients or physicians...would not question the modest benefits of this drug if it were 'low-risk, low-cost, and easy to use,'" but they noted that "none of these three characteristics" apply to it.

They emphasized that obtaining a clearer picture of the balance between the benefits of this drug and its risks requires gathering more data, including beyond the 18-month mark.

They also criticized the low percentage of people of color included in the trial, despite being more affected by the disease.

Susan Kohlhaas from the organization "Alzheimer's Research UK" stated that the "first generation" of these drugs "is not perfect," but it is a significant step in the right direction.

Professor Giles Hardingham, a pharmacology professor at the University of Edinburgh, said that it represents an important achievement that paves the way for several future treatments.

 

 

 

 

 

 

AFP