American experts recommend authorizing the drug from… "Eli Lily" For Alzheimer’s disease

Written By Mark

An advisory committee composed of American experts recommended the approval of a drug for Alzheimer’s disease developed by the Eli Lilly group. This expert opinion paves the way for health authorities to issue a positive decision to approve the use of the new drug.

Eleven independent experts at the request of the US Food and Drug Administration (FDA) to review the clinical trial data unanimously agreed that the drug “donanemab” has proven effective in those who are still in an early stage of the disease.

In a second vote, experts noted that the benefits of this drug outweigh its risks.

Expert Sarah Dolan believed that there is a “huge” need for new medicines, although patients and doctors will need to receive “a lot of information” about the Eli Lilly drug to ensure good follow-up.

However, a number of experts expressed their regret about the lack of data regarding some population groups within the clinical trial, especially with regard to African Americans.

The committee’s recommendation is not binding on the FDA, but it is rare for the agency not to follow it.

The drug belongs to a new class of drugs against Alzheimer’s, for which patients and their families have great hopes.

Donanemab is taken intravenously and works to destroy plaques formed by proteins in patients’ brains called amyloid.

Side effects

A clinical trial showed that “donanemab” slows the progression of this degenerative disease, but in return it causes severe side effects in some patients, as it may lead to brain bleeding.

In the spring, the US Food and Drug Administration decided to delay the expected licensing of the drug in order to further scrutinize the data and obtain the opinion of this expert committee.

In May 2023, the FDA licensed the first similar drug against Alzheimer’s, which was put on the market under the name “Leqembi”, produced by the Japanese pharmaceutical group “Eisai” in cooperation with its American counterpart, “Biogen”, and this drug is its component. Active.

Its decisions regarding Alzheimer’s disease have become the subject of intense scrutiny since the controversy over the first drug in this category, Aduhelm from Biogen, whose authorization by the Authority in 2021 – under hasty procedures – was subject to severe criticism, and it was soon withdrawn from the market.

Research into combating Alzheimer’s has been stagnant for decades, and Adohelm was the first drug against the disease to be licensed since 2003.