The US drug regulator (FDA) concluded this Thursday the authorization for the use of a new drug that delays the symptoms of Alzheimer’s neurodegenerative disease, after verifying its efficacy in a clinical trial.
The drug ‘lecanemab’, which will receive the trade name of Leqembi, has been developed by the Japanese pharmaceutical Eisai, in collaboration with the American Biogen.
Justifying the full authorization of the drug, the interim director of the Department of Neurosciences of the Center for Drug Evaluation and Research of the FDA, Teresa Buracchio, refers, quoted in a statement, that a latest clinical trial confirmed that Leqembi “is safe and effective” for Alzheimer’s patients.
The clinical trial, involving 1,800 patients, demonstrated a “significant reduction” in cognitive decline, allowing the drug to be given full approval on Thursday after preliminary approval in January, according to the FDA.
The US regulator admitted, in the statement, that the new drug can cause side effects such as headaches or inflammation and bleeding in the brain, which disappear over time, but which, in rare cases, can be fatal.
The FDA advises against the use of Leqembi, administered intravenously, in patients taking anticoagulant medications because it increases the risk of brain hemorrhage.
The drug should be prescribed to patients with a slight degradation of cognitive functions and in the early stages of the disease.
Another drug developed by the same pharmaceutical companies against the early stages of Alzheimer’s disease, Aduhelm, had already been authorized by the FDA.
However, the decision was criticized by experts due to a lack of evidence on its effectiveness.
In April 2022, Biogen withdrew the marketing authorization application for Aduhelm in Europe.
Alzheimer’s disease, the most common form of dementia, is characterized by global, progressive, and irreversible degradation of various cognitive functions, such as memory, attention, concentration, language, and thinking.
Source: TSF
