The highly anticipated Alzheimer’s drug lecanemab was granted accelerated approval status this afternoon by the FDA, offering hope where there has been little for patients and their families affected by the devastating disease.
So what should patients and their families make of today’s news? Here we answer some of the top questions surrounding the drug.The FDA granted accelerated approval to Leqembi after it showed positive trial results in slowing the progression of early-stage disease.for drugs that treat serious conditions and fill an unmet medical need while drugs continue to be studied in larger trials.
could benefit from the newly approved treatment will only be available to those who can pay out-of-pocket. Without coverage, people simply won’t be able to get the treatment."reports that with accelerated approval, drugmaker Eisai is expected to immediately apply for full FDA approval, which wouldn’t be likely to come before later this year. Full approval could help clear the path for Medicare coverage of the drug.
“There are things about the use of the drug in the real world that we need to work out, especially in the context of people with comorbidities,” he says.is a little different, Fillit says. The patient, who had a stroke, showed signs of vasculitis, or inflammation of the blood vessels.
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