Leqembi, which aims to reduce cognitive decline, was approved for patients who have not yet reached an advanced stage of the disease.
US health authorities today gave full approval to a new Alzheimer’s treatment, expanding access to it through the federal health insurance system.
Leqembi, which aims to reduce cognitive decline, was approved for patients who have not yet reached an advanced stage of the disease.
The drug was approved in January by the US Food and Drug Administration (FDA) under an accelerated process. Additional research analysis now allows for its full approval, the FDA explained in a statement.
Leqembi is given intravenously every two weeks and was developed by the Japanese pharmaceutical company Eisai and the American Biogen.
It was priced at $26,500 per year per patient.
Leqembi is part of a new generation of treatments that target a protein called beta-amyloid that forms plaques in patients’ brains.
This medicine is the first that clearly demonstrated a reduction in cognitive impairment (by 27%) in a clinical trial.
Without curing patients, it can allow disease progression to slow somewhat.
“This treatment, although not a cure, can give people more time (…) to maintain their independence and do the things they love,” said Joan Peek, president of the Alzheimer’s Association.
Affected people “deserve the opportunity to discuss and decide, with their doctor and their family, whether this treatment is right for them,” he added.
But it comes with a warning: it can have serious side effects, such as swelling or bleeding in the brain, which can prove fatal.
Source :Skai
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