The US Food and Drug Administration on Friday approved the Alzheimer’s drug lecanemab developed by Eisai Co Ltd and Biogen Inc for patients in the earliest stages of the mind-wasting disease.
Biogen shares, which had been halted, were up 5% at $285.19.
Initial patient access will be limited by a number of factors including reimbursement decisions from Medicare, the US government insurance program for Americans aged 65 and older who represent some 90% of individuals likely to be eligible for Leqembi. The US Centers for Medicare & Medicaid Services said on Friday that current coverage restrictions for drugs approved under the accelerated pathway could be reconsidered based on its ongoing review of available information.
Lecanemab 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.
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