US health authorities on Friday authorized a new Alzheimer’s drug aimed at reducing cognitive decline in patients suffering from this neurodegenerative disease, a long-awaited treatment after the failed launch of a previous drug with a similar mechanism a year and a half ago.
The new treatment, which will be marketed under the name Leqembi, is now recommended by the US Food and Drug Administration (FDA) for patients who have not yet reached a very advanced stage of the disease.
27% reduction in cognitive decline
This treatment represents “an important step forward in our battle to effectively treat Alzheimer’s disease,” which affects an estimated 6.5 million Americans, the FDA said in a statement.
The agency also mentions the results of larger clinical trials, recently published in a scientific journal. Conducted in nearly 1,800 people followed for 18 months, they revealed a 27% reduction in cognitive decline in patients treated with lecanemab.
But the study also revealed serious adverse effects: some of the treated patients suffered brain haemorrhages. Also, at least one person who received the treatment has died. The FDA included a warning about the risk of bleeding in the drug information.
Long-term studies are required
However, as reported New York Timesa recent study published in the New England Journal of Medicine he said “longer studies are needed to determine the efficacy and safety” of the drug.
Still according to information from the American newspaper, the treatment would cost 26,500 dollars a year (25,000 euros).
The FDA also acknowledged that mistakes were made in the 2021 approval process for another Alzheimer’s drug, Adulhem. In December, two US congressional committees noted that the approval process had been marred by numerous irregularities.
Source: BFM TV
