The United States Food and Drug Administration (FDA) approved this Thursday (07.07.2023) for the first time the use of a drug that slows down the symptoms of Alzheimer’s, after verifying its effectiveness.
the drug lecanemab, which will receive the trade name of Leqembiwas developed by the Japanese pharmaceutical company Eisai, and has been shown to be effective in slowing down the effects of neurodegenerative disease.
The FDA had already granted the drug an accelerated approval last January, but there was still a final clinical trial to be carried out that has given satisfactory results.
“This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.Teresa Buracchio, acting director of the Office of Neuroscience at the FDA’s Center for Drug Evaluation and Research, said in a statement.
An achievement, despite the risk of adverse effects
Alzheimer’s, which affects 6.5 million people in the United States alone, is an irreversible neurodegenerative disease that slowly destroys memory and the ability to perform tasks. According to the FDA, the latest study, conducted on 1,800 patients, demonstrated a “significant reduction” in cognitive decline.
The drug, which is administered intravenously, has raised concerns about the possibility that it causes inflammation and bleeding in the brain, a condition that occurs in some Alzheimer’s patients, known as ARIA.
The FDA admitted in its statement that Leqembi can cause side effects such as headache or even ARIA, which generally resolve over time but in rare cases can be fatal. The regulator recommends against prescribing Leqembi in patients using anticoagulant medication, as it increases the risk of brain haemorrhages.
The drug should also be used in patients with mild cognitive impairment and in early stages of Alzheimer’s disease, the FDA stressed.