Eisai and Biogen’s Alzheimer’s treatment Leqembi (lecanemab) has received full approval by the US Food and Drug Administration (FDA). This marks the first full approval for an Alzheimer’s disease treatment in decades and clears the path to Medicare reimbursement, which previously required providers contribute data to a patient registry.
According to Ryan Cross, “Leqembi won an accelerated approval in January for people with mild cognitive impairment or mild dementia and evidence of amyloid pathology from a brain scan or spinal tap. The full approval was based on data from a large study showing that an 18-month course of the drug slowed a common measure of cognitive decline by 27%, compared with placebo infusions.”
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(Source: Endpoints News, July 6th, 2023)