The US drug regulator (FDA) on Thursday approved the use of a new drug that slows the symptoms of neurodegenerative Alzheimer’s disease after verifying its effectiveness in a clinical trial.
The drug ‘lecanemab’, which will be given the commercial name Leqembi, was developed by the Japanese pharmaceutical company Eisai in collaboration with the American company Biogen.
To justify the full approval of the drug, Teresa Buracchio, the interim director of the Neuroscience Division of the FDA’s Center for Drug Evaluation and Research, refers to, quoted in a statement, that a latest clinical trial confirmed that Leqembi is “safe and effective” for Alzheimer’s patients.
The clinical trial, which involved 1,800 patients, showed a “significant reduction” in cognitive decline, allowing the drug to be fully approved Thursday after preliminary approval in January, the FDA said.
The US regulator admitted in the statement that the new drug could cause side effects, such as headaches or inflammation and bleeding in the brain, that subside over time, but could be fatal in rare cases.
The FDA does not recommend the use of Leqembi, administered intravenously, in patients taking anticoagulants because it increases the risk of cerebral hemorrhage.
The drug should be prescribed to patients with a slight decline in 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, was already approved by the FDA.
However, the decision was criticized by experts for the lack of evidence for 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 the global, progressive and irreversible degradation of several cognitive functions, such as memory, attention, concentration, language and thinking.
Source: DN
