The drug aims to slow the advance of the neurodegenerative disease. Nearly all previous experimental drugs using the same approach have failed.
The drug, to be sold under the brand Leqembi, belongs to a class of treatments that aims to slow advance of the neurodegenerative disease by removing sticky clumps of the toxic protein beta amyloid from the brain.Eisai said the drug would launch at an annual price of $26,500.
Initial patient access will be limited by a number of factors including reimbursement decisions from Medicare, the U.S. government insurance program for Americans aged 65 and older who represent some 90% of individuals likely to be eligible for Leqembi. The drug is intended for patients with mild cognitive impairment or early Alzheimer's dementia, a population that doctors believe represents a small segment of the estimated 6 million Americans currently living with the memory-robbing illness.Leqembi was approved under the FDA's accelerated review process, an expedited pathway that speeds access to a drug based on its impact on underlying disease-related biomarkers believed to predict a clinical benefit.
this week that the autopsy of a 65-year-old lecanemab patient who suffered a stroke showed that emergency treatment with a standard clot-busting drug led to fatal brain hemorrhaging. At least one other patient in a follow-on study of lecanemab died from brain hemorrhages, raising concerns that blood-thinners may increase risks of dangerous brain swelling.Our Standards:
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