Eisai, Biogen Get FDA Advisers’ Support for Alzheimer’s Drug (1)

June 9, 2023, 8:43 PM UTC

Eisai Co.’s Alzheimer’s disease drug developed with Biogen Inc. gained support from advisers to US regulators, paving the way for a likely full regulatory approval that could lead to broader insurance coverage.

The six advisers to the Food and Drug Administration voted unanimously to recommend the traditional approval of Leqembi, which is the first treatment clearly shown to slow the progression of the disease that impacts more than 6 million Americans and some 55 million people around the world. The favorable vote was widely expected by analysts after the FDA’s staff supported the drug in a report Wednesday.

The ...

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