FDA Brief Supports Full Approval for Alzheimer’s Drug Leqembi

In a newly released brief, the US Food and Drug Administration (FDA) vocalized support for the full approval of Eisai and Biogen’s Alzheimer’s drug Leqembi. The brief, which comes before an FDA adcomm this Friday, June 9^th, shows that the agency considers the drug’s efficacy well-supported by evidence from a recent study and that the risk of adverse events does not rule out full approval.

According to Erik Saganowski, “In the study, investigators tested Leqembi against placebo in patients with mild cognitive impairment due to Alzheimer’s or mild Alzheimer’s dementia. The study measured the drug’s efficacy on an endpoint called the Clinical Dementia Rating-Sum of Boxes at 18 months of treatment. On that primary endpoint and three secondary clinical endpoints, Leqembi met the mark in the trial, the FDA said.”

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