FDA approves new drug to treat Alzheimer's
March 13, 2023
The US drug regulatory agency, FDA, approved a new drug lecanemab for the treatment of Alzheimer's disease on Friday (January 6, 2023). According to the WHO (World Health Organization), neurodegenerative diseases affect more than 55 million people worldwide.
"This treatment option is the latest in targeting and influencing the underlying process of Alzheimer's disease, rather than just treating the symptoms of the disease," said Billy Dunn, director of the Office of Neuroscience at the Center for Drug Evaluation and Research at FDA. the full statement (98 KB, English).
Despite the warm reception from the scientific community, an article in the journal Nature on Friday (January 6) also recommended further research to determine the efficacy and safety of lecanemab.
The effectiveness of Leqembi (trade name of the drug) was evaluated in a double-blind study involving 2 different groups of 1,795 participants in the early stages of the disease, 897 of whom received a placebo – substance with no effect – and the rest, the real drug. This means that neither doctors nor patients know who actually received the treatment.
The results showed a significant 27% reduction in disease-induced cognitive decline in the drug-treated group, a percentage that the developer's lab considered significant.
Drug review by the FDA is done through the “Accelerated Approval Pathway”. The agency uses the loophole to evaluate drugs that treat serious or life-threatening illnesses.
The drug was developed in collaboration between the Japanese biotechnology company Eisai and the American Biogen.
How Leqembi works
Leqembi works with amyloid plaques, a protein present in the brains of people with Alzheimer's disease. The accumulation of this substance can affect the patient's mental capacity, interrupting communication between cells. According to research, the drug aims to reduce the levels of this protein, thus delaying the effects of the disease.
The most serious side effects reported were brain swelling and bleeding. Patients who carried two copies of the APOE4 gene variant – which increases the risk of Alzheimer's disease – were more likely to develop brain swelling from the drug.
According to the leaflet of Leqembi, the drug should only be used in patients with early and mild stages of the disease.
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