The FDA's decision will allow the drug known as Leqembi to be widely available and covered through Medicare.
In the pivotal 18-month-long clinical trial that secured Leqembi’s approval, the drug was found to slow the progression of cognitive decline by 27% in patients compared to those on placebo. Patients also performed better on tests of their daily functioning and had lower levels of amyloid in their brains, however. One of the most common complications is
known as amyloid-related imaging abnormalities , which can be diagnosed via MRI. ARIAs tend to be caused by temporary swelling in the brain, but sometimes, they can be a sign of life-threatening bleeding. Most cases of ARIA resolve without problem, with many patients experiencing no symptoms, but there have been several deaths linked to ARIAs and these drugs.The risk of ARIA and severe ARIA seems to be higher in those carrying a particular Alzheimer-related mutation called ApoE ε4.
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